Panels › Orthopedic › Product code MBI · Class 2
Fastener, Fixation, Nondegradable, Soft Tissue
Regulation 888.3040
33510(k)s in 12 months (607 all time)
0recalls in 12 months (113 all time)
104recalls that name a 510(k)
Top companies in MBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Arthrex, Inc. | 53 | 1 |
| ArthroCare Corporation | 31 | 1 |
| Axya Medical, Inc. | 5 | 24 |
| Smith & Nephew | 23 | 5 |
| Riverpoint Medical | 23 | 1 |
| Parcus Medical | 23 | 0 |
| Innovasive Devices, Inc. | 22 | 0 |
| Biomet, Inc. | 10 | 10 |
| CONMED Corporation | 16 | 1 |
| Stryker | 10 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 30, 1998 | K974136 | CRANIOFACIAL ANCHORS Biomet, Inc. | MBI |
| Jan 30, 1998 | K970119 | MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX Mitek Products | MBI |
| Dec 1, 1997 | K973323 | ACL CLIP-IN Innovasive Devices, Inc. | MBI |
| Nov 10, 1997 | K973009 | MITEK NON ABSORBABLE POLYPROPYLENE H FIX Mitek Products | MBI |
| Oct 28, 1997 | K963502 | CSCO FOREHEAD FIXATION SYSTEM Howmedica Corp. | MBI |
| Oct 9, 1997 | K973015 | MULTITAK SS SUTURE SYSTEM Bonutti Research | MBI |
| Oct 9, 1997 | K972622 | STRAIGHT-IN BONE SCREW FIXATION SYSTEM Influence, Inc. | MBI |
| Sep 26, 1997 | K972438 | INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER Innovasive Devices, Inc. | MBI |
| Aug 26, 1997 | K972356 | INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER Innovasive Devices, Inc. | MBI |
| Aug 7, 1997 | K971922 | INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER Innovasive Devices, Inc. | MBI |
| Jul 30, 1997 | K971802 | VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION Louisville Laboratories, Inc. | MBI |
| Jul 30, 1997 | K971791 | VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION Louisville Laboratories, Inc. | MBI |
| Jul 30, 1997 | K971723 | FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) Arthrex, Inc. | MBI |
| Jul 9, 1997 | K971332 | AMS MAINSTAY UROLOGIC BONE ANCHOR American Medical Systems, Inc. | MBI |
| Jun 27, 1997 | K971282 | ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM Wrightmedicaltechnologyinc | MBI |
| Jun 25, 1997 | K971144 | MULTITAK SS SUTURE SYSTEM Bonutti Research | MBI |
| Jun 25, 1997 | K971139 | BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT Boston Scientific Corp | MBI |
| Jun 20, 1997 | K963932 | PRELOADED SOFT TISSUE ANCHOR Linvatec Corp. | MBI |
| Apr 30, 1997 | K970423 | INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE Innovasive Devices, Inc. | MBI |
| Apr 23, 1997 | K970292 | IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW Influence, Inc. | MBI |
| Apr 16, 1997 | K970316 | INNOVASIVE 8MM LIGAMENT FASTENER Innovasive Devices, Inc. | MBI |
| Mar 25, 1997 | K970089 | INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER Innovasive Devices, Inc. | MBI |
| Feb 24, 1997 | K964945 | INNOVASIVE DEVICES ROTATOR CUFF FASTNER Innovasive Devices, Inc. | MBI |
| Feb 18, 1997 | K965111 | STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008 R. Thomas Grotz, M.D., Inc. | MBI |
| Feb 12, 1997 | K965069 | ANSPACH SUTURE ANCHOR The Anspach Effort, Inc. | MBI |
| Feb 7, 1997 | K964927 | STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8 R. Thomas Grotz, M.D., Inc. | MBI |
| Feb 6, 1997 | K964786 | ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM Wrightmedicaltechnologyinc | MBI |
| Feb 3, 1997 | K964532 | MULTITAK SS SUTURE SYSTEM Bonutti Research | MBI |
| Jan 10, 1997 | K964324 | MULTITAK SS SUTURE SYSTEM Bonutti Research | MBI |
| Nov 25, 1996 | K963686 | ANSPACH SUTURE ANCHOR (MODIFIED) The Anspach Effort, Inc. | MBI |
| Nov 13, 1996 | K963288 | LM BONE ANCHOR Li Medical Technologies, Inc. | MBI |
| Nov 12, 1996 | K963812 | LM BONE ANCHOR (ORTHOPEDICS) Li Medical Technologies, Inc. | MBI |
| Nov 6, 1996 | K962511 | MITEK MICRO ANCHOR Mitek Products | MBI |
| Nov 4, 1996 | K963402 | INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER Innovasive Devices, Inc. | MBI |
| Oct 3, 1996 | K961094 | MITEK THREADED ANCHOR (MODIFICATION) Mitek Products | MBI |
| Oct 2, 1996 | K963217 | ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM Wrightmedicaltechnologyinc | MBI |
| Oct 2, 1996 | K963200 | QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM Wrightmedicaltechnologyinc | MBI |
| Aug 27, 1996 | K962397 | STATAK SOFT TISSUE ATTACHMENT DEVICE Zimmer, Inc. | MBI |
| Jul 30, 1996 | K962194 | MLI SOFT TISSUE SCREW & WASHER SYSTEM Medicinelodge, Inc. | MBI |
| Apr 30, 1996 | K960825 | LM ANCHOR OR OTHER PROPRIETARY NAME Li Medical Technologies, Inc. | MBI |
| Apr 23, 1996 | K954683 | QUESTLOCK ACL FIXATOR Wrightmedicaltechnologyinc | MBI |
| Apr 18, 1996 | K960516 | FASTAK SUTURE ANCHOR Arthrex, Inc. | MBI |
| Apr 18, 1996 | K960439 | LM BONE ANCHOR Li Medical Technologies, Inc. | MBI |
| Apr 17, 1996 | K960448 | LM ANCHOR Li Medical Technologies, Inc. | MBI |
| Apr 3, 1996 | K934183 | BONUTTI ANCHOR Apogee Medical Products, Inc. | MBI |
| Mar 21, 1996 | K954338 | INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER Innovasive Devices, Inc. | MBI |
| Feb 20, 1996 | K953954 | PRELOADED SOFT TISSUE ANCHOR Linvatec Corp. | MBI |
| Jan 31, 1996 | K953560 | MITEK THREADED ANCHOR (FASTIN) Mitek Surgical Products, Inc. | MBI |
| Dec 29, 1995 | K953877 | MITEK GII ANCHOR Mitek Surgical Products, Inc. | MBI |
| Dec 8, 1995 | K952237 | INNOVASICE 2.8MM & 3.5MM ROC SUTURE BONE FASTENER Innovasive Devices, Inc. | MBI |
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