The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Wedge Suture Anchor.
| Device ID | K983557 |
| 510k Number | K983557 |
| Device Name: | STRYKER WEDGE SUTURE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Todd Miller |
| Correspondent | Todd Miller Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-13 |
| Decision Date | 1998-12-18 |
| Summary: | summary |