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 6 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K012503 | METAL SCREW ANCHOR | Biomet Manufacturing, Inc. | 2001-10-22 | Traditional | PDF ↗ |
| K011912 | MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000 | Axya Medical, Inc. | 2001-08-31 | Traditional | PDF ↗ |
| K011007 | TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 | Arthrex, Inc. | 2001-06-12 | Traditional | PDF ↗ |
| K011390 | BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM | Disc-O-Tech Medical Technologies, Ltd. | 2001-06-06 | Special | PDF ↗ |
| K010457 | ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924 | Arthrex, Inc. | 2001-05-14 | Traditional | PDF ↗ |
| K002829 | DJ ORTHOPEDICS FEMORAL ANCHOR | Dj Orthopedics, LLC | 2001-03-26 | Traditional | PDF ↗ |
| K003960 | DJ ORTHOPEDICS TIBIAL ANCHOR | Dj Orthopedics, LLC | 2001-03-21 | Traditional | PDF ↗ |
| K003971 | AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR | Axya Medical, Inc. | 2001-03-21 | Traditional | PDF ↗ |
| K003648 | FREEDLAND TENSION SYSTEM | Etzem Technologies, Inc. | 2001-02-23 | Traditional | PDF ↗ |
| K010121 | STERILE BUTTON PLATE | Synthes (Usa) | 2001-02-09 | Special | PDF ↗ |
| K002600 | LITWIN CRUICATE ANCHOR | Instrument Makar, Inc. | 2000-11-15 | Traditional | PDF ↗ |
| K994364 | SYNTHES BUTTON PLATE | Synthes (Usa) | 2000-03-15 | Traditional | PDF ↗ |
| K000279 | STAPLETAC2 BONE ANCHOR SYSTEM | American Medical Systems, Inc. | 2000-03-01 | Special | PDF ↗ |
| K993657 | ACUMED SUTURE ANCHOR | Acu Med, Inc. | 2000-01-13 | Traditional | PDF ↗ |
| K993261 | TALON ANCHOR SNAP-PAK | Mitek Products | 1999-12-02 | Traditional | PDF ↗ |
| K992458 | RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454 | Innovasive Devices, Inc. | 1999-10-14 | Traditional | PDF ↗ |
| K992377 | RC TACK | Innovasive Devices, Inc. | 1999-10-08 | Traditional | PDF ↗ |
| K990295 | BONE ANCHOR SYSTEM III (BAS III) | Boston Scientific Corp | 1999-03-05 | Traditional | PDF ↗ |
| K990156 | MULTITAK SS BUTTONS | Bonutti Research | 1999-03-05 | Traditional | PDF ↗ |
| K990160 | MICROTAC-BONE ANCHOR SYSTEM | Influence, Inc. | 1999-02-16 | Special | PDF ↗ |
| K990095 | STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM | Influence, Inc. | 1999-02-01 | Traditional | PDF ↗ |
| K982751 | IMPLEX SCREW AND WASHER SYSTEM | Implex Corp. | 1999-02-01 | Traditional | PDF ↗ |
| K983560 | INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER | Innovasive Devices, Inc. | 1999-01-28 | Traditional | PDF ↗ |
| K984200 | STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE | R. Thomas Grotz, M.D., Inc. | 1999-01-21 | Traditional | PDF ↗ |
| K983557 | STRYKER WEDGE SUTURE ANCHOR | Stryker Endoscopy | 1998-12-18 | Traditional | PDF ↗ |
| K983169 | POLYMER THREADED ANCHOR | Orthopaedic Biosystems, Ltd. | 1998-12-16 | Traditional | PDF ↗ |
| K983818 | MITEK FASTIN RC ANCHOR | Mitek Products | 1998-11-23 | Special | PDF ↗ |
| K983056 | INNOVASIVE TIBIAL FASTENER | Innovasive Devices, Inc. | 1998-10-13 | Traditional | PDF ↗ |
| K982571 | KSEA FLIPPTACK | KARL STORZ Endoscopy-America, Inc. | 1998-09-22 | Traditional | PDF ↗ |
| K982169 | SHERLOCK THREADED SUTURE ANCHOR (TIN COATED) | Doctor'S Research Group, Inc. | 1998-09-14 | Traditional | PDF ↗ |
| K982155 | SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM | Influence, Inc. | 1998-08-31 | Traditional | PDF ↗ |
| K974847 | 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235 | Arthrex, Inc. | 1998-08-06 | Traditional | PDF ↗ |
| K981692 | MENISCAL REPAIR DEVICE | Linvatec Corp. | 1998-07-27 | Traditional | PDF ↗ |
| K981967 | WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE | Arthrotek/Biomet, Inc. | 1998-07-17 | Traditional | PDF ↗ |
| K981764 | LM ANCHOR | Li Medical Technologies, Inc. | 1998-07-13 | Abbreviated | PDF ↗ |
| K981755 | LM ANCHOR | Li Medical Technologies, Inc. | 1998-07-13 | Abbreviated | PDF ↗ |
| K981688 | ANSPACH SUTURE ANCHOR | The Anspach Effort, Inc. | 1998-07-13 | Traditional | PDF ↗ |
| K981193 | INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER | Innovasive Devices, Inc. | 1998-06-16 | Traditional | PDF ↗ |
| K980595 | DEPUY ORTHOTECH CATERA SUTURE ANCHOR | DePuy Orthopaedics, Inc. | 1998-05-11 | Traditional | PDF ↗ |
| K980491 | INNOVASIVE LINX TIBIAL LIGAMENT FASTENER | Innovasive Devices, Inc. | 1998-04-29 | Traditional | PDF ↗ |
| K980334 | INNOVASIVE 10MM LINX HT LIGAMENT FASTENER | Innovasive Devices, Inc. | 1998-04-27 | Traditional | PDF ↗ |
| K973874 | ACL CLIP-IN PLATE | Innovasive Devices, Inc. | 1998-04-24 | Traditional | PDF ↗ |
| K973775 | HARPOON SUTURE ANCHORS | Biomet, Inc. | 1998-04-16 | Traditional | PDF ↗ |
| K980103 | ACUMED SUTURE ANCHOR | Acu Med, Inc. | 1998-03-16 | Traditional | PDF ↗ |
| K974049 | INNOVASIVE LINX BT 10MM LIGAMENT FASTENER | Innovasive Devices, Inc. | 1998-02-18 | Traditional | PDF ↗ |
| K974345 | MITEK KNOTLESS ANCHOR | Mitek Products | 1998-02-13 | Traditional | PDF ↗ |
| K972326 | PEBA ANCHOR/SUTURE COMBINATION | Orthopaedic Biosystems, Ltd. | 1998-02-06 | Traditional | PDF ↗ |
| K970119 | MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX | Mitek Products | 1998-01-30 | Traditional | PDF ↗ |
| K974136 | CRANIOFACIAL ANCHORS | Biomet, Inc. | 1998-01-30 | Traditional | PDF ↗ |
| K973323 | ACL CLIP-IN | Innovasive Devices, Inc. | 1997-12-01 | Traditional | PDF ↗ |
| K973009 | MITEK NON ABSORBABLE POLYPROPYLENE H FIX | Mitek Products | 1997-11-10 | Traditional | PDF ↗ |
| K963502 | CSCO FOREHEAD FIXATION SYSTEM | Howmedica Corp. | 1997-10-28 | Traditional | PDF ↗ |
| K973015 | MULTITAK SS SUTURE SYSTEM | Bonutti Research | 1997-10-09 | Traditional | PDF ↗ |
| K972622 | STRAIGHT-IN BONE SCREW FIXATION SYSTEM | Influence, Inc. | 1997-10-09 | Traditional | PDF ↗ |
| K972438 | INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER | Innovasive Devices, Inc. | 1997-09-26 | Traditional | PDF ↗ |
| K972356 | INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER | Innovasive Devices, Inc. | 1997-08-26 | Traditional | PDF ↗ |
| K971922 | INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER | Innovasive Devices, Inc. | 1997-08-07 | Traditional | PDF ↗ |
| K971802 | VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION | Louisville Laboratories, Inc. | 1997-07-30 | Traditional | PDF ↗ |
| K971791 | VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION | Louisville Laboratories, Inc. | 1997-07-30 | Traditional | PDF ↗ |
| K971723 | FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) | Arthrex, Inc. | 1997-07-30 | Traditional | PDF ↗ |
| K971332 | AMS MAINSTAY UROLOGIC BONE ANCHOR | American Medical Systems, Inc. | 1997-07-09 | Traditional | PDF ↗ |
| K971282 | ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM | Wrightmedicaltechnologyinc | 1997-06-27 | Traditional | PDF ↗ |
| K971139 | BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT | Boston Scientific Corp | 1997-06-25 | Traditional | PDF ↗ |
| K971144 | MULTITAK SS SUTURE SYSTEM | Bonutti Research | 1997-06-25 | Traditional | PDF ↗ |
| K963932 | PRELOADED SOFT TISSUE ANCHOR | Linvatec Corp. | 1997-06-20 | Traditional | PDF ↗ |
| K970423 | INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE | Innovasive Devices, Inc. | 1997-04-30 | Traditional | PDF ↗ |
| K970292 | IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW | Influence, Inc. | 1997-04-23 | Traditional | PDF ↗ |
| K970316 | INNOVASIVE 8MM LIGAMENT FASTENER | Innovasive Devices, Inc. | 1997-04-16 | Traditional | PDF ↗ |
| K970089 | INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER | Innovasive Devices, Inc. | 1997-03-25 | Traditional | PDF ↗ |
| K964945 | INNOVASIVE DEVICES ROTATOR CUFF FASTNER | Innovasive Devices, Inc. | 1997-02-24 | Traditional | PDF ↗ |
| K965111 | STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008 | R. Thomas Grotz, M.D., Inc. | 1997-02-18 | Traditional | PDF ↗ |
| K965069 | ANSPACH SUTURE ANCHOR | The Anspach Effort, Inc. | 1997-02-12 | Traditional | PDF ↗ |
| K964927 | STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8 | R. Thomas Grotz, M.D., Inc. | 1997-02-07 | Traditional | PDF ↗ |
| K964786 | ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM | Wrightmedicaltechnologyinc | 1997-02-06 | Traditional | PDF ↗ |
| K964532 | MULTITAK SS SUTURE SYSTEM | Bonutti Research | 1997-02-03 | Traditional | PDF ↗ |
| K964324 | MULTITAK SS SUTURE SYSTEM | Bonutti Research | 1997-01-10 | Traditional | PDF ↗ |
| K963686 | ANSPACH SUTURE ANCHOR (MODIFIED) | The Anspach Effort, Inc. | 1996-11-25 | Traditional | PDF ↗ |
| K963288 | LM BONE ANCHOR | Li Medical Technologies, Inc. | 1996-11-13 | Traditional | PDF ↗ |
| K963812 | LM BONE ANCHOR (ORTHOPEDICS) | Li Medical Technologies, Inc. | 1996-11-12 | Traditional | PDF ↗ |
| K962511 | MITEK MICRO ANCHOR | Mitek Products | 1996-11-06 | Traditional | PDF ↗ |
| K963402 | INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER | Innovasive Devices, Inc. | 1996-11-04 | Traditional | PDF ↗ |
| K961094 | MITEK THREADED ANCHOR (MODIFICATION) | Mitek Products | 1996-10-03 | Traditional | PDF ↗ |
| K963217 | ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM | Wrightmedicaltechnologyinc | 1996-10-02 | Traditional | PDF ↗ |
| K963200 | QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM | Wrightmedicaltechnologyinc | 1996-10-02 | Traditional | PDF ↗ |
| K962397 | STATAK SOFT TISSUE ATTACHMENT DEVICE | Zimmer, Inc. | 1996-08-27 | Traditional | PDF ↗ |
| K962194 | MLI SOFT TISSUE SCREW & WASHER SYSTEM | Medicinelodge, Inc. | 1996-07-30 | Traditional | PDF ↗ |
| K960825 | LM ANCHOR OR OTHER PROPRIETARY NAME | Li Medical Technologies, Inc. | 1996-04-30 | Traditional | PDF ↗ |
| K954683 | QUESTLOCK ACL FIXATOR | Wrightmedicaltechnologyinc | 1996-04-23 | Traditional | PDF ↗ |
| K960439 | LM BONE ANCHOR | Li Medical Technologies, Inc. | 1996-04-18 | Traditional | PDF ↗ |
| K960516 | FASTAK SUTURE ANCHOR | Arthrex, Inc. | 1996-04-18 | Traditional | PDF ↗ |
| K960448 | LM ANCHOR | Li Medical Technologies, Inc. | 1996-04-17 | Traditional | PDF ↗ |
| K934183 | BONUTTI ANCHOR | Apogee Medical Products, Inc. | 1996-04-03 | Traditional | PDF ↗ |
| K954338 | INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER | Innovasive Devices, Inc. | 1996-03-21 | Traditional | PDF ↗ |
| K953954 | PRELOADED SOFT TISSUE ANCHOR | Linvatec Corp. | 1996-02-20 | Traditional | PDF ↗ |
| K953560 | MITEK THREADED ANCHOR (FASTIN) | Mitek Surgical Products, Inc. | 1996-01-31 | Traditional | PDF ↗ |
| K953877 | MITEK GII ANCHOR | Mitek Surgical Products, Inc. | 1995-12-29 | Traditional | PDF ↗ |
| K952237 | INNOVASICE 2.8MM & 3.5MM ROC SUTURE BONE FASTENER | Innovasive Devices, Inc. | 1995-12-08 | Traditional | PDF ↗ |
| K951451 | PEBA ANCHOR (MULTIPLE SIZES) | Orthopaedic Biosystems, Ltd. | 1995-10-31 | Traditional | PDF ↗ |
| K953702 | WASHER | Linvatec Corp. | 1995-10-25 | Traditional | PDF ↗ |
| K953264 | QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM | Wrightmedicaltechnologyinc | 1995-10-20 | Traditional | PDF ↗ |
Product code MBI · Class II · Orthopedic. Data: openFDA.