The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Iconix All Suture Anchors.
| Device ID | K133671 |
| 510k Number | K133671 |
| Device Name: | ICONIX ALL SUTURE ANCHORS |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | STRYKER CORP. HOWMEDICA OSTEONICS Denver, CO 80206 |
| Contact | Kelly Kucharczyk |
| Correspondent | Kelly Kucharczyk STRYKER CORP. HOWMEDICA OSTEONICS 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 | 2013-11-29 |
| Decision Date | 2014-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327176934 | K133671 | 000 |
| 37613327176927 | K133671 | 000 |
| 37613252450369 | K133671 | 000 |
| 37613252450352 | K133671 | 000 |
| 37613252450345 | K133671 | 000 |
| 37613252450338 | K133671 | 000 |