The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Iconix With Needles.
| Device ID | K151201 |
| 510k Number | K151201 |
| Device Name: | Stryker ICONIX With Needles |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Stryker 5670 Greenwood Plaza Blvd, Suite 200 Greenwood Village, CO 80111 |
| Contact | Taylor White |
| Correspondent | Taylor White Stryker 5670 Greenwood Plaza Blvd, Suite 200 Greenwood Village, CO 80111 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-05 |
| Decision Date | 2015-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327283465 | K151201 | 000 |
| 37613327283458 | K151201 | 000 |
| 37613327283441 | K151201 | 000 |
| 37613327283434 | K151201 | 000 |