The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Fast-fix Flex.
| Device ID | K203393 |
| 510k Number | K203393 |
| Device Name: | FAST-FIX FLEX |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Crystal Morales |
| Correspondent | Crystal Morales Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-18 |
| Decision Date | 2021-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556780800 | K203393 | 000 |
| 00885556772737 | K203393 | 000 |
| 00885556804711 | K203393 | 000 |
| 00885556804704 | K203393 | 000 |