The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Cannulated Screws And Washers.
| Device ID | K111994 |
| 510k Number | K111994 |
| Device Name: | SMITH & NEPHEW CANNULATED SCREWS AND WASHERS |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Maureen Whitson |
| Correspondent | Maureen Whitson SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-13 |
| Decision Date | 2011-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556297490 | K111994 | 000 |
| 00885556296899 | K111994 | 000 |
| 00885556296844 | K111994 | 000 |
| 00885556296790 | K111994 | 000 |
| 00885556296745 | K111994 | 000 |
| 00885556296691 | K111994 | 000 |
| 00885556296646 | K111994 | 000 |
| 00885556296592 | K111994 | 000 |
| 00885556296547 | K111994 | 000 |
| 00885556296943 | K111994 | 000 |
| 00885556296998 | K111994 | 000 |
| 00885556297049 | K111994 | 000 |
| 00885556297445 | K111994 | 000 |
| 00885556297391 | K111994 | 000 |
| 00885556297346 | K111994 | 000 |
| 00885556297292 | K111994 | 000 |
| 00885556297247 | K111994 | 000 |
| 00885556297193 | K111994 | 000 |
| 00885556297148 | K111994 | 000 |
| 00885556297094 | K111994 | 000 |
| 00885556296493 | K111994 | 000 |