The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Hoffmann 3 Modular External Fixation System.
| Device ID | K121252 |
| 510k Number | K121252 |
| Device Name: | HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM |
| 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 | 2012-04-25 |
| Decision Date | 2012-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327008005 | K121252 | 000 |
| 07613252442783 | K121252 | 000 |
| 04546540716187 | K121252 | 000 |