The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Hoffmann Lrf System.
| Device ID | K163656 |
| 510k Number | K163656 |
| Device Name: | Hoffmann LRF System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Paul Nelson |
| Correspondent | Paul Nelson Stryker GmbH 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 | 2016-12-23 |
| Decision Date | 2017-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327297751 | K163656 | 000 |
| 07613327294286 | K163656 | 000 |
| 07613327294279 | K163656 | 000 |
| 07613327294255 | K163656 | 000 |
| 07613327294231 | K163656 | 000 |
| 07613327294200 | K163656 | 000 |