The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Hoffmann Lrf (limb Reconstruction Frame) System.
| Device ID | K113327 |
| 510k Number | K113327 |
| Device Name: | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) 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 | 2011-11-10 |
| Decision Date | 2012-03-29 |
| Summary: | summary |