The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Cannulated Captured Screw.
| Device ID | K133662 |
| 510k Number | K133662 |
| Device Name: | SMITH & NEPHEW CANNULATED CAPTURED SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Katherine Marcaccio |
| Correspondent | Katherine Marcaccio 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 | 2013-11-29 |
| Decision Date | 2014-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556658673 | K133662 | 000 |
| 00885556658352 | K133662 | 000 |
| 00885556650257 | K133662 | 000 |
| 00885556650240 | K133662 | 000 |
| 00885556650233 | K133662 | 000 |
| 00885556650226 | K133662 | 000 |
| 00885556645925 | K133662 | 000 |
| 00885556645918 | K133662 | 000 |
| 00885556280362 | K133662 | 000 |
| 00885556280317 | K133662 | 000 |
| 00885556280263 | K133662 | 000 |
| 00885556280218 | K133662 | 000 |
| 00885556280164 | K133662 | 000 |
| 00885556280119 | K133662 | 000 |
| 00885556658505 | K133662 | 000 |
| 00885556658512 | K133662 | 000 |
| 00885556658529 | K133662 | 000 |
| 00885556658666 | K133662 | 000 |
| 00885556658659 | K133662 | 000 |
| 00885556658642 | K133662 | 000 |
| 00885556658635 | K133662 | 000 |
| 00885556658628 | K133662 | 000 |
| 00885556658611 | K133662 | 000 |
| 00885556658604 | K133662 | 000 |
| 00885556658598 | K133662 | 000 |
| 00885556658581 | K133662 | 000 |
| 00885556658574 | K133662 | 000 |
| 00885556658550 | K133662 | 000 |
| 00885556658543 | K133662 | 000 |
| 00885556658536 | K133662 | 000 |
| 00885556280065 | K133662 | 000 |