The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Hoffmann 3.
| Device ID | K122284 |
| 510k Number | K122284 |
| Device Name: | HOFFMANN 3 |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | STRYKER CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Estela Celi |
| Correspondent | Estela Celi STRYKER CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-30 |
| Decision Date | 2012-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327096293 | K122284 | 000 |
| 07613252477211 | K122284 | 000 |
| 07613252477228 | K122284 | 000 |
| 07613252505877 | K122284 | 000 |
| 07613327010176 | K122284 | 000 |
| 37613327072403 | K122284 | 000 |
| 37613327072427 | K122284 | 000 |
| 37613327072687 | K122284 | 000 |
| 37613327072694 | K122284 | 000 |
| 07613327079098 | K122284 | 000 |
| 07613327089172 | K122284 | 000 |
| 07613327091502 | K122284 | 000 |
| 07613327092035 | K122284 | 000 |
| 07613327092592 | K122284 | 000 |
| 07613327096286 | K122284 | 000 |
| 04546540704993 | K122284 | 000 |