The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Fast-fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,fast Fix 360 Ab Meniscal Repair System, Straight,.
| Device ID | K092508 |
| 510k Number | K092508 |
| Device Name: | FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Julie Acker |
| Correspondent | Julie Acker 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 | 2009-08-17 |
| Decision Date | 2010-01-28 |
| Summary: | summary |