The following data is part of a premarket notification filed by Stryker Trauma Ag with the FDA for Hoffmann Lrf (limb Reconstruction Frame) System.
| Device ID | K140961 |
| 510k Number | K140961 |
| Device Name: | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Stryker Trauma AG BOHNACKERWEG 1 Selzach, CH Ch-2545 |
| Contact | Nesli Karakaya, Rac |
| Correspondent | Nesli Karakaya, Rac Stryker Trauma AG BOHNACKERWEG 1 Selzach, CH Ch-2545 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-15 |
| Decision Date | 2014-11-10 |
| Summary: | summary |