FDA Product Code
FDA Product Code MBI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3040
510(k) Clearances — 604 records · page 4 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K151230 | Arthrex FiberTak Anchors | Arthrex, Inc. | 2015-06-19 | Special | PDF ↗ |
| K150424 | JuggerStitch Meniscal Repair Device | Biomet Manufacturing Corp | 2015-05-15 | Traditional | PDF ↗ |
| K143473 | Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles | Cayenne Medical, Inc. | 2015-03-25 | Traditional | PDF ↗ |
| K150166 | Extremity Medical Suture Anchor | Extremity Medical, LLC | 2015-02-23 | Special | PDF ↗ |
| K143392 | Quattro Bolt Tenodesis Screw | Cayenne Medical, Inc. | 2015-01-23 | Traditional | PDF ↗ |
| K142643 | Stabilynx PEEK Suture Anchor | D3 Dc, LLC /Stabilynx, Inc. | 2014-12-15 | Traditional | PDF ↗ |
| K142574 | 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, | Depuy Mitek, A Johnson & Johnson Company | 2014-10-24 | Special | PDF ↗ |
| K142653 | G-Lok and G-Lok XL Extender | T.A.G. Medical Products Corporation, Ltd. | 2014-10-16 | Special | PDF ↗ |
| K142230 | Apollo Suture Anchor System and Titan Screws | Valeris Medical | 2014-09-10 | Special | PDF ↗ |
| K140476 | ARTHREX FIBERTAK SUTURE ANCHOR | Arthrex, Inc. | 2014-08-13 | Traditional | PDF ↗ |
| K141011 | G-FORCE GEN 2 SUTURE ANCHOR SYSTEM | Wrightmedicaltechnologyinc | 2014-07-30 | Traditional | PDF ↗ |
| K141711 | PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE | Pontis Orthopaeeics, LLC | 2014-07-24 | Special | PDF ↗ |
| K140879 | BIOSURE HEALICOIL PK INTERFERENCE SCREW | Smith & Nephew, Inc. | 2014-07-21 | Traditional | PDF ↗ |
| K140324 | RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL | Depuy Mitek, A Johnson and Johnson Company | 2014-07-07 | Traditional | PDF ↗ |
| K133579 | MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS | Pontis Orthopaedics, LLC | 2014-06-26 | Traditional | PDF ↗ |
| K140925 | ACUMED SUTURE ANCHOR SYSTEM | Acumed, LLC | 2014-05-20 | Special | PDF ↗ |
| K140604 | MULTIFIX S KNOTLESS FIXATION SYSTEM | ArthroCare Corporation | 2014-05-14 | Special | PDF ↗ |
| K132724 | ICONN ANSWER SUTURE ANCHOR | Iconn Orthopedics, LLC | 2014-04-17 | Traditional | PDF ↗ |
| K133235 | THREADED PEEK K-WIRE | Mtp Solutions, LLC | 2014-04-07 | Traditional | PDF ↗ |
| K133777 | TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR | Tornier, Inc. | 2014-04-04 | Traditional | PDF ↗ |
| K133606 | N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL | ArthroCare Corporation | 2014-04-01 | Traditional | PDF ↗ |
| K133469 | ACUMED SUTURE ANCHOR SYSTEM | Acumed, LLC | 2014-03-10 | Traditional | PDF ↗ |
| K133036 | APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS | Amendia, Inc. | 2014-03-06 | Traditional | PDF ↗ |
| K133671 | ICONIX ALL SUTURE ANCHORS | Stryker Corp. | 2014-02-28 | Traditional | PDF ↗ |
| K133757 | GFS II STANDARD, GFS II LARGE, GFS MIMI | Parcus Medical, LLC | 2014-02-04 | Special | PDF ↗ |
| K133229 | TITANIUM SUTURE ANCHOR | Mtp Solutions, LLC | 2014-01-30 | Traditional | PDF ↗ |
| K133727 | Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU | ArthroCare Corporation | 2014-01-16 | Special | PDF ↗ |
| K133224 | Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES | Conmed Corporation | 2014-01-03 | Special | PDF ↗ |
| K132867 | SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM | Cayenne Medical, Inc. | 2013-12-30 | Traditional | PDF ↗ |
| K132783 | EXOSHAPE DUO SOFT TISSUE FASTENER | MedShape, Inc. | 2013-12-09 | Traditional | PDF ↗ |
| K130467 | POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE | MedShape, Inc. | 2013-12-05 | Traditional | PDF ↗ |
| K122437 | NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS | Biomet Sports Medicine | 2013-10-18 | Traditional | PDF ↗ |
| K132461 | A.I.M. SUTURE ANCHOR | Anchor Innovation Medical, Inc. | 2013-10-16 | Traditional | PDF ↗ |
| K131769 | CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM | Pivot Medical, Inc. | 2013-10-07 | Traditional | PDF ↗ |
| K132513 | Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER | ArthroCare Corporation | 2013-09-19 | Special | PDF ↗ |
| K132632 | TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES | Tornier, Inc. | 2013-09-19 | Special | PDF ↗ |
| K132590 | 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA | ArthroCare Corporation | 2013-09-17 | Special | PDF ↗ |
| K131635 | ROTATION MEDICAL BONE STAPLE (RMB STAPLE) | Rotation Medical, Inc. | 2013-08-29 | Traditional | PDF ↗ |
| K131325 | QUATTRO GL SUTURE ANCHOR | Cayenne Medical, Inc. | 2013-08-16 | Traditional | PDF ↗ |
| K130814 | RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM | Depuy Mitek, A Johnson & Johnson Company | 2013-08-01 | Traditional | PDF ↗ |
| K130033 | TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO | Biomet Manufacturing Corp | 2013-08-01 | Traditional | PDF ↗ |
| K131182 | MULTIFIX S KNOTLESS FIXATION DEVICE | Arthocare Corporation | 2013-07-29 | Traditional | PDF ↗ |
| K131035 | Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM | Linvatec Corporation D/B/A Conmed Linvatec | 2013-07-02 | Special | PDF ↗ |
| K131683 | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) | Depuy Mitek, Inc., A Johnson and Johnson Company | 2013-06-27 | Special | PDF ↗ |
| K130217 | ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM | OrthoPediatrics Corp. | 2013-06-20 | Traditional | PDF ↗ |
| K130539 | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) | Depuy Mitek, A Johnson & Johnson Company | 2013-05-21 | Traditional | PDF ↗ |
| K130458 | KNOTLESS FIBERTAK SUTURE ANCHOR | Arthrex, Inc. | 2013-05-03 | Traditional | PDF ↗ |
| K122059 | ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS | Smith & Nephew, Inc. | 2013-03-18 | Traditional | PDF ↗ |
| K123485 | JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF | Biomet Sports Medicine | 2013-03-18 | Traditional | PDF ↗ |
| K130351 | NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER | Pivot Medical, Inc. | 2013-03-14 | Special | PDF ↗ |
| K123350 | ECLIPSE SOFT TISSUE FASTENER | MedShape, Inc. | 2013-03-07 | Traditional | PDF ↗ |
| K120740 | COLS® FIXATION SYSTEM | Fournitures Hospitalieres Industrie | 2013-03-05 | Special | PDF ↗ |
| K130196 | SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR | Arthrocare Corp. | 2013-02-27 | Special | PDF ↗ |
| K123651 | CINCHLOCK KNOTLESS SUTURE ANCHOR | Pivot Medical | 2013-02-21 | Traditional | PDF ↗ |
| K123425 | TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL | Smith & Nephew, Inc. | 2013-02-20 | Traditional | PDF ↗ |
| K123240 | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT | ArthroCare Corporation | 2013-02-14 | Traditional | PDF ↗ |
| K122805 | PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR | Parcus Medical, LLC | 2013-02-05 | Traditional | PDF ↗ |
| K123579 | FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL | Smith & Nephew, Inc. | 2013-01-23 | Special | PDF ↗ |
| K122336 | Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM | Eleven Blade Solutions, Inc. | 2013-01-09 | Traditional | PDF ↗ |
| K123341 | ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON | Arthrex, Inc. | 2012-12-21 | Traditional | PDF ↗ |
| K122954 | CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 | Foundry Newcoxi, Inc. | 2012-12-19 | Traditional | PDF ↗ |
| K120356 | NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD | Ncs Lab Srl | 2012-12-11 | Traditional | PDF ↗ |
| K121354 | MICRO/MINI N-PK(F) BONE ANCHOR | Anulex Technologies, Inc. | 2012-11-09 | Traditional | PDF ↗ |
| K121356 | MICRO/MINI N-PK(H) BONE ANCHOR | Anulex Technologies, Inc. | 2012-11-09 | Traditional | PDF ↗ |
| K122314 | QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY | Cayenne Medical, Inc. | 2012-10-31 | Traditional | PDF ↗ |
| K122463 | APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W | Cayenne Medical, Inc. | 2012-10-11 | Special | PDF ↗ |
| K122123 | 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED | Depuy Mitek, Inc., A Johnson and Johnson Company | 2012-10-02 | Traditional | PDF ↗ |
| K120943 | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER | ArthroCare Corporation | 2012-09-21 | Traditional | PDF ↗ |
| K120509 | STRYKER ALL SUTURE ANCHORS | Stryker | 2012-07-26 | Traditional | PDF ↗ |
| K120824 | 3.9MM REELX STT SUTURE ANCHOR SYSTEM | Stryker Corp. | 2012-07-18 | Traditional | PDF ↗ |
| K121018 | BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN | Smith & Nephew, Inc. | 2012-06-22 | Traditional | PDF ↗ |
| K120841 | APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR | Kfx Medical | 2012-06-07 | Special | PDF ↗ |
| K120942 | PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC | Parcus Medical, LLC | 2012-04-20 | Special | PDF ↗ |
| K120096 | MULTIFIX P KNOTLESS FIXATION DEVICE | ArthroCare Corporation | 2012-03-27 | Traditional | PDF ↗ |
| K113274 | FOOTPRINT ULTRA PK SUTURE ANCHOR | Smith & Nephew, Inc. | 2012-03-06 | Traditional | PDF ↗ |
| K113297 | KNOTILUS ANCHOR SYSTEM | T.A.G. Medical Products Corporation, Ltd. | 2012-03-02 | Traditional | PDF ↗ |
| K120155 | ARTHREX KNOTLESS SUTURETAK ANCHOR | Arthrex, Inc. | 2012-02-17 | Special | PDF ↗ |
| K112526 | TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS | Smith & Nephew, Inc. | 2012-01-31 | Traditional | PDF ↗ |
| K113294 | SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR | Smith & Nephew, Inc. | 2012-01-20 | Traditional | PDF ↗ |
| K113730 | PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS | Parcus Medical, LLC | 2012-01-17 | Special | PDF ↗ |
| K112814 | CUFFINK | Cayenne Medical, Inc. | 2012-01-17 | Traditional | PDF ↗ |
| K112417 | VARIOUS | Depuy Mitek, A Johnson & Johnson Company | 2012-01-13 | Traditional | PDF ↗ |
| K112960 | LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE | Cayenne Medical, Inc. | 2012-01-09 | Traditional | PDF ↗ |
| K113299 | ROG SUTURE ANCHOR | Rog Sports Medicine, Inc. | 2011-12-15 | Special | PDF ↗ |
| K112876 | CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 | Cayenne Medical, Inc. | 2011-12-15 | Traditional | PDF ↗ |
| K112991 | MODIFIED ROG SUTURE ANCHOR | Rog Sports Medicine, Inc. | 2011-12-08 | Special | PDF ↗ |
| K112296 | LATERAL BUTTON | T.A.G. Medical Products Corporation, Ltd. | 2011-12-01 | Traditional | PDF ↗ |
| K111716 | KNOTLESS SUTURE FIXATION SYSTEM | Core Essence Orthopaedics | 2011-11-10 | Traditional | PDF ↗ |
| K112965 | NANO SUTURE ANCHOR | Linvatec Corporation D/B/A Conmed Linvatec | 2011-11-02 | Special | PDF ↗ |
| K110800 | META-LOCK SUTURE ANCHOR SYSTEM | Tarsus Medical, Inc. | 2011-09-27 | Traditional | PDF ↗ |
| K111661 | ARTHREX SCAPHOLUNATE ANCHOR | Arthrex, Inc. | 2011-08-19 | Special | PDF ↗ |
| K110879 | BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR | Biomet Sports Medicine | 2011-08-19 | Traditional | PDF ↗ |
| K111044 | SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE | ArthroCare Corporation | 2011-08-09 | Traditional | PDF ↗ |
| K111779 | Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 | Conmed Linvatec | 2011-08-08 | Traditional | PDF ↗ |
| K111590 | ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR | Rog Sports Medicine, Inc. | 2011-08-08 | Special | PDF ↗ |
| K111631 | GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. | Depuy Mitek, A Johnson & Johnson Company | 2011-07-22 | Traditional | PDF ↗ |
| K111399 | SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 | Arthrocare Corp. | 2011-07-20 | Special | PDF ↗ |
| K111397 | TITAN TI SUTURE ANCHOR SYSTEM | Arthrocare Corp. | 2011-07-12 | Special | PDF ↗ |
| K110545 | SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK) | Smith & Nephew, Inc. | 2011-06-24 | Traditional | PDF ↗ |
| K111564 | MAXFIRE MARXMEN MENISCAL REPAIR DEVICE | Biomet Sports Medicine | 2011-06-16 | Special | PDF ↗ |
Product code MBI · Class II · Orthopedic. Data: openFDA.