The following data is part of a premarket notification filed by Stryker with the FDA for Iconix Xbraid Tt With Needles, Nanotack Tt Suture Anchor.
| Device ID | K173074 |
| 510k Number | K173074 |
| Device Name: | ICONIX XBraid TT With Needles, NanoTack TT Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Stryker 5670 Greenwood Plaza Blvd. Suite 200 Greenwood Village, CO 80111 |
| Contact | Jacob Scheenstra |
| Correspondent | Jacob Scheenstra 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 | 2017-09-29 |
| Decision Date | 2018-04-04 |
| Summary: | summary |