The following data is part of a premarket notification filed by Stryker with the FDA for Xbraid Tt Suture Tape.
| Device ID | K162310 |
| 510k Number | K162310 |
| Device Name: | XBraid TT Suture Tape |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| 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 | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-17 |
| Decision Date | 2016-11-10 |
| Summary: | summary |