The following data is part of a premarket notification filed by Stryker with the FDA for Iconix Tt All Suture Anchor.
| Device ID | K170098 |
| 510k Number | K170098 |
| Device Name: | ICONIX TT All Suture Anchor |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-11 |
| Decision Date | 2017-03-31 |
| Summary: | summary |