The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Hoffmann Lrf (limb Reconstruction Frame) System.
| Device ID | K153377 |
| 510k Number | K153377 |
| Device Name: | Hoffmann LRF (Limb Reconstruction Frame) 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 | 2015-11-23 |
| Decision Date | 2016-04-11 |
| Summary: | summary |