The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Wedge Suture Anchor System.
| Device ID | K041310 |
| 510k Number | K041310 |
| Device Name: | STRYKER WEDGE SUTURE ANCHOR SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-17 |
| Decision Date | 2004-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154644513 | K041310 | 000 |
| 07613154644506 | K041310 | 000 |
| 37613154175018 | K041310 | 000 |
| 37613154019855 | K041310 | 000 |
| 37613154015307 | K041310 | 000 |