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 5 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K111471 | EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) | Medshape Solutions, Inc. | 2011-06-10 | Special | PDF ↗ |
| K110773 | TORNIER INSITE FT SUTURE ANCHOR | Tornier, Inc. | 2011-06-02 | Traditional | PDF ↗ |
| K110781 | 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP | Arthrocare Corp. | 2011-05-27 | Special | PDF ↗ |
| K110473 | NANOTACK SUTURE ANCHOR 1.4MM | Pivot Medical | 2011-05-25 | Traditional | PDF ↗ |
| K110230 | ROG KNOTLESS SUTURE ANCHOR | Rog Sports Medicine, Inc. | 2011-05-19 | Traditional | PDF ↗ |
| K110229 | ROG SUTURE ANCHOR 5.5MM, 2.9MM | Rog Sports Medicine, Inc. | 2011-05-18 | Traditional | PDF ↗ |
| K103262 | QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM | Tornier, Inc. | 2011-04-05 | Traditional | PDF ↗ |
| K110145 | BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR | Biomet, Inc. | 2011-03-04 | Traditional | PDF ↗ |
| K102539 | ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM | Shoulder Options, Inc. | 2011-02-24 | Traditional | PDF ↗ |
| K103145 | HAMMERLOC TM TIBIAL FIXATION DEVICE | Biomet Sports Medicine | 2011-02-09 | Traditional | PDF ↗ |
| K110164 | 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL | Arthrocare Corp. | 2011-02-07 | Special | PDF ↗ |
| K101616 | THE GRAPPLR AND GRAPPLR EXTENDER | Tag Medical Corp. | 2011-01-06 | Traditional | PDF ↗ |
| K103060 | ARTHREX TIBIAL GRAFTBOLT | Arthrex, Inc. | 2011-01-05 | Special | PDF ↗ |
| K102660 | BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS | Smith & Nephew Endoscopy, Inc. | 2010-12-13 | Traditional | PDF ↗ |
| K101126 | PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS | Core Essence Orthopaedics, Inc. | 2010-12-02 | Traditional | PDF ↗ |
| K101437 | SPEEDFIX SUTURE SYSTEM | Arthrocare Corp. | 2010-10-29 | Special | PDF ↗ |
| K102262 | ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL | Arthrocare Corp. | 2010-10-21 | Traditional | PDF ↗ |
| K102443 | INTRAFIX TIBIAL SHEATH | Depuy Mitek, A Johnson & Johnson Company | 2010-10-20 | Special | PDF ↗ |
| K101063 | SLEEVE WITH ZIPLOOP FIXATION DEVICES | Biomet Sports Medicine | 2010-06-23 | Traditional | PDF ↗ |
| K101448 | OPUS SPEEDSCREW SYSTEM | Arthrocare Corp. | 2010-06-21 | Special | PDF ↗ |
| K100630 | G-FORCE PEEK SUTURE ANCHOR SYSTEM | Wrightmedicaltechnologyinc | 2010-06-11 | Traditional | PDF ↗ |
| K101175 | KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER | Kfx Medical | 2010-05-20 | Special | PDF ↗ |
| K101184 | TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006 | Arthrocare Corp. | 2010-05-18 | Special | PDF ↗ |
| K100159 | SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR | Smith & Nephew Inc., Endoscopy Div. | 2010-04-19 | Traditional | PDF ↗ |
| K093935 | SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR | Smith & Nephew, Inc. | 2010-04-05 | Traditional | PDF ↗ |
| K100579 | G-FORCE TI SUTURE ANCHOR SYSTEM | Wrightmedicaltechnologyinc | 2010-03-26 | Special | PDF ↗ |
| K093912 | ARTHREX TIBIAL GRAFTBOLT | Arthrex, Inc. | 2010-03-18 | Traditional | PDF ↗ |
| K093943 | BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM | Smith & Nephew Inc., Endoscopy Div. | 2010-03-05 | Traditional | PDF ↗ |
| K093897 | SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR | Smith & Nephew Inc., Endoscopy Div. | 2010-03-04 | Traditional | PDF ↗ |
| K092836 | OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141 | Depuy Mitek, A Johnson & Johnson Company | 2010-02-04 | Traditional | PDF ↗ |
| K092998 | CONMED LINVATEC INTERCEPT IMPLANT | Linvatec Corp. | 2009-12-23 | Traditional | PDF ↗ |
| K093428 | SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR | Smith & Nephew Endoscopy, Inc. | 2009-12-17 | Traditional | PDF ↗ |
| K093228 | SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR | Smith & Nephew, Inc. | 2009-12-15 | Traditional | PDF ↗ |
| K092914 | WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES | Medshape Solutions | 2009-12-09 | Special | PDF ↗ |
| K091094 | PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264 | Parcus Medical, LLC | 2009-09-30 | Traditional | PDF ↗ |
| K091870 | TORNIER, PITON FIXATION IMPLANT SYSTEM | Tornier | 2009-09-21 | Traditional | PDF ↗ |
| K090923 | PARCUS GRAFT FIXATION SYSTEM | Parcus Medical, LLC | 2009-06-30 | Traditional | PDF ↗ |
| K091549 | CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM | Linvatec Corp. | 2009-06-23 | Special | PDF ↗ |
| K091503 | MAGNUM MP FIXATION DEVICE | Arthrocare Corp. | 2009-06-17 | Special | PDF ↗ |
| K090615 | OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE | Arthrocare Corp. | 2009-06-03 | Traditional | PDF ↗ |
| K090530 | SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01 | Ross Creek Medical, Inc. | 2009-05-20 | Traditional | PDF ↗ |
| K090380 | MAGNUM M FIXATION DEVICE | Arthrocare Corp. | 2009-03-13 | Special | PDF ↗ |
| K083609 | KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE | Kfx Medical | 2009-03-06 | Traditional | PDF ↗ |
| K090075 | PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258 | Parcus Medical, LLC | 2009-03-06 | Traditional | PDF ↗ |
| K083635 | SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW | Smith & Nephew Endoscopy, Inc. | 2009-01-30 | Traditional | PDF ↗ |
| K083226 | SMITH & NEPHEW PEEK INTERFERENCE SCREW | Smith & Nephew Endoscopy, Inc. | 2009-01-30 | Traditional | PDF ↗ |
| K083151 | EXTREMITY MEDICAL SUTURE ANCHOR | Extremity Medical, LLC | 2009-01-22 | Traditional | PDF ↗ |
| K083150 | G-FORCE TENODESIS SCREW | Wrightmedicaltechnologyinc | 2009-01-15 | Traditional | PDF ↗ |
| K083240 | OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES | Arthrocare Corp. | 2009-01-12 | Traditional | PDF ↗ |
| K082729 | RIMCLOSE BONE ANCHOR | Anulex Technologies, Inc. | 2008-12-19 | Traditional | PDF ↗ |
| K083070 | TOGGLELOC SYSTEM | Biomet Sports Medicine | 2008-12-16 | Traditional | PDF ↗ |
| K081348 | TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD | TriMed, Inc. | 2008-10-17 | Traditional | PDF ↗ |
| K081511 | 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S | Smith & Nephew, Inc. | 2008-08-26 | Traditional | PDF ↗ |
| K081497 | OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) | Arthrocare Corp. | 2008-07-28 | Special | PDF ↗ |
| K081598 | SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE | Kfx Medical | 2008-07-03 | Special | PDF ↗ |
| K080447 | SURGICRAFT SCREW FIXATION SYSTEM | Surgicraft , Ltd. | 2008-06-13 | Traditional | PDF ↗ |
| K080335 | TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM | Tornier, Inc. | 2008-04-23 | Traditional | PDF ↗ |
| K080229 | 5.5 MM SUTURE LOCK BONE SCREW ANCHOR | Kfx Medical | 2008-02-29 | Special | PDF ↗ |
| K073481 | THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES | Conmed Linvatec | 2008-01-07 | Special | PDF ↗ |
| K073226 | CINCH KNOTLESS FIXATION IMPLANT SYSTEM | C2m Medical, Inc. | 2007-12-07 | Special | PDF ↗ |
| K072063 | KFX TISSUE FIXATION SYSTEM AND ACCESSORIES | Kfx Medical | 2007-10-26 | Traditional | PDF ↗ |
| K070773 | AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR | Axya Medical, Inc. | 2007-10-11 | Traditional | PDF ↗ |
| K071704 | SLEEVE AND BUTTON SOFT TISSUE DEVICES | Biomet Sports Medicine, Inc. | 2007-09-17 | Traditional | PDF ↗ |
| K070780 | CONMED LINVATEC XO BUTTON | Conmed Linvatec | 2007-08-21 | Traditional | PDF ↗ |
| K071586 | BIORAPTOR 2.3 PK SUTURE ANCHOR | Smith & Nephew Inc., Endoscopy Division | 2007-08-17 | Traditional | PDF ↗ |
| K071520 | RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X | Core Essence Orthopaedics, LLC | 2007-08-10 | Traditional | PDF ↗ |
| K071374 | OPUS TWINLOCK KNOTLESS FIXATION DEVICE | Arthrocare Corp. | 2007-08-02 | Traditional | PDF ↗ |
| K070882 | STRYKER PEEK TWINLOOP TAC | Stryker Endoscopy | 2007-07-20 | Traditional | PDF ↗ |
| K071569 | ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER | Biomet, Inc. | 2007-07-02 | Special | PDF ↗ |
| K070758 | STRYKER PEEK ZIP SUTURE ANCHOR | Stryker Endoscopy | 2007-05-16 | Traditional | PDF ↗ |
| K070908 | SMITH & NEPHEW KINSA RC SUTURE ANCHOR | Smith & Nephew Inc., Endoscopy Division | 2007-05-16 | Traditional | PDF ↗ |
| K070227 | OPUS MAGNUM PI KNOTLESS FIXATION DEVICE | Arthrocare Corp. | 2007-04-16 | Traditional | PDF ↗ |
| K070167 | ENDOBUTTON DIRECT | Smith & Nephew Inc., Endoscopy Division | 2007-04-12 | Traditional | PDF ↗ |
| K062739 | CINCH BONE ANCHOR SYSTEM | Sapphire Medical, Inc. | 2007-02-13 | Traditional | PDF ↗ |
| K063577 | FEMORAL INTRAFIX SCREW AND SHEATH | Johnson & Johnson Company | 2007-01-25 | Traditional | PDF ↗ |
| K063499 | MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM | Scandius Biomedical, Inc. | 2006-12-19 | Special | PDF ↗ |
| K061294 | KFX KNOTLESS FIXATION SYSTEM | Kfx Medical | 2006-07-19 | Traditional | PDF ↗ |
| K061349 | OPUS LABRALOCK P KNOTLESS FIXATION DEVICE | Arthrocare Corp. | 2006-07-14 | Traditional | PDF ↗ |
| K061154 | KINSA SUTURE ANCHOR | Smith & Nephew, Inc. | 2006-06-08 | Traditional | PDF ↗ |
| K053461 | EZLOC FEMORAL FIXATION DEVICE | Arthrotek, Inc. | 2006-02-03 | Traditional | PDF ↗ |
| K052810 | SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM | Scandius Biomedical, Inc. | 2005-12-20 | Traditional | PDF ↗ |
| K052572 | ANSPACH KNOTLESS ANCHOR | The Anspach Effort, Inc. | 2005-12-05 | Traditional | PDF ↗ |
| K052491 | AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR | Axya Medical, Inc. | 2005-10-07 | Special | PDF ↗ |
| K051069 | NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER | Arthrotek, Inc. | 2005-06-29 | Traditional | PDF ↗ |
| K050227 | THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER | Linvatec Corp. | 2005-03-02 | Special | PDF ↗ |
| K042914 | OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE | Opus Medical, Inc. | 2004-11-12 | Special | PDF ↗ |
| K042460 | TI - SCREW ANCHOR SP | Arthrotek, Inc. | 2004-10-29 | Traditional | PDF ↗ |
| K041713 | SUPER REVO HERCULINE SUTURE ANCHOR | Linvatec Corp. | 2004-07-22 | Special | PDF ↗ |
| K041440 | OPUS MAGNUM ANCHOR WITH INSERTER | Opus Medical, Inc. | 2004-06-25 | Special | PDF ↗ |
| K041310 | STRYKER WEDGE SUTURE ANCHOR SYSTEM | Stryker Endoscopy | 2004-06-14 | Special | PDF ↗ |
| K041261 | FEMORAL HOOK | Arthrotek, Inc. | 2004-06-07 | Special | PDF ↗ |
| K033838 | TITANIUM TOGGLE BUTTON(S) | Biomet Manufacturing, Inc. | 2004-02-13 | Traditional | PDF ↗ |
| K023963 | ADHOC CLAW | Future Medical Systems, Inc. | 2003-05-05 | Traditional | PDF ↗ |
| K022853 | ENDOTACK | KARL STORZ Endoscopy-America, Inc. | 2002-11-25 | Traditional | PDF ↗ |
| K022827 | ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR | Linvatec Corp. | 2002-11-22 | Traditional | PDF ↗ |
| K022207 | AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM | Axya Medical, Inc. | 2002-10-04 | Traditional | PDF ↗ |
| K020172 | OPUS MAGNUM ANCHOR & INSTRUMENT SET | Opus Medical, Inc. | 2002-07-22 | Abbreviated | PDF ↗ |
| K013553 | PRE-LOADED ULTRAFIX RC | Linvatec Corp. | 2001-12-19 | Traditional | PDF ↗ |
| K013334 | ENDOFLIP | Arthocare Corporation | 2001-12-13 | Traditional | PDF ↗ |
| K013557 | LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW | Walter Lorenz Surgical, Inc. | 2001-11-16 | Special | PDF ↗ |
Product code MBI · Class II · Orthopedic. Data: openFDA.