The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Gts Sleeve And Gts Tapered Screw.
| Device ID | K040542 |
| 510k Number | K040542 |
| Device Name: | SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Marion W Gordon |
| Correspondent | Marion W Gordon SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-02 |
| Decision Date | 2004-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010510976 | K040542 | 000 |
| 03596010510969 | K040542 | 000 |
| 03596010510952 | K040542 | 000 |