The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Ultra Fast-fix Meniscal Repair System, Smith & Nephew Ultra Fast-fix Ab Meniscal Repair System, Smith & N.
| Device ID | K121861 |
| 510k Number | K121861 |
| Device Name: | SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Karin Desjardins |
| Correspondent | Karin Desjardins 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 | 2012-06-26 |
| Decision Date | 2012-10-18 |
| Summary: | summary |