The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Tfcc Fast-fix Kit.
| Device ID | K132079 |
| 510k Number | K132079 |
| Device Name: | TFCC FAST-FIX KIT |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Jason Sells |
| Correspondent | Jason Sells SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-05 |
| Decision Date | 2013-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554032154 | K132079 | 000 |