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 |
|---|---|---|---|
| Oct 31, 1995 | K951451 | PEBA ANCHOR (MULTIPLE SIZES) Orthopaedic Biosystems, Ltd. | MBI |
| Oct 25, 1995 | K953702 | WASHER Linvatec Corp. | MBI |
| Oct 20, 1995 | K953264 | QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM Wrightmedicaltechnologyinc | MBI |
| Sep 15, 1995 | K934327 | ARTHREX SUTURE ANCHOR SCREW SYSTEM Arthrex, Inc. | MBI |
| Sep 8, 1995 | K951565 | INNOVASIVE DEVICES ROTATOR CUFF FASTENER Innovasive Devices, Inc. | MBI |
| Aug 23, 1995 | K953459 | ACUFEX TAG ANCHOR Acufex Microsurgical, Inc. | MBI |
| Feb 1, 1995 | K944831 | INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENER Innovasive Devices, Inc. | MBI |
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