The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Alpha Vent Peek Suture Anchor.
| Device ID | K211502 |
| 510k Number | K211502 |
| Device Name: | Alpha Vent PEEK Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Stryker Endoscopy 5900 Optical Ct. San Jose, CA 95138 |
| Contact | Christie Samsa |
| Correspondent | Christie Samsa 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 | 2021-05-14 |
| Decision Date | 2021-08-04 |