The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Humeral Staple.
| Device ID | K041355 |
| 510k Number | K041355 |
| Device Name: | HUMERAL STAPLE |
| Classification | Pin, Fixation, Smooth |
| Applicant | SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | John Reabe |
| Correspondent | John Reabe SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-20 |
| Decision Date | 2004-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556046593 | K041355 | 000 |
| 03596010652379 | K041355 | 000 |