The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Peek Zip Suture Anchor.
| Device ID | K070758 |
| 510k Number | K070758 |
| Device Name: | STRYKER PEEK ZIP SUTURE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Erica A Walters |
| Correspondent | Erica A Walters Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-20 |
| Decision Date | 2007-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613252232491 | K070758 | 000 |
| 37613154644552 | K070758 | 000 |
| 37613154644545 | K070758 | 000 |
| 37613154644538 | K070758 | 000 |
| 37613154644521 | K070758 | 000 |