The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Self-punching Iconix.
| Device ID | K171465 |
| 510k Number | K171465 |
| Device Name: | Stryker Self-Punching ICONIX |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Stryker 5900 Optical Ct San Jose, CA 95138 |
| Contact | Katie Farraro |
| Correspondent | Katie Farraro Stryker 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 | 2017-05-18 |
| Decision Date | 2017-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327374217 | K171465 | 000 |
| 37613327374200 | K171465 | 000 |