The following data is part of a premarket notification filed by Stryker with the FDA for Stryker All Suture Anchors.
| Device ID | K120509 |
| 510k Number | K120509 |
| Device Name: | STRYKER ALL SUTURE ANCHORS |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Stryker 3201 E. 3RD AVE Denver, CO 80206 |
| Contact | Kelly Kucharczyk |
| Correspondent | Kelly Kucharczyk Stryker 3201 E. 3RD AVE Denver, CO 80206 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-21 |
| Decision Date | 2012-07-26 |
| Summary: | summary |