The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Mini-mender Meniscal Repair System.
| Device ID | K032901 |
| 510k Number | K032901 |
| Device Name: | STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Melissa Murphy |
| Correspondent | Melissa Murphy Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-17 |
| Decision Date | 2003-12-02 |
| Summary: | summary |