510(k) K153377 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Hoffmann LRF (Limb Reconstruction Frame) System
| Applicant | Stryker GmbH, Mahwah NJ, US |
| Decision | Substantially Equivalent, Apr 11, 2016 |
| Received | Nov 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153377
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2023 | Stryker GmbH stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consol Open, Classified |
KTT | None listed |
| Apr 26, 2017 | Stryker Howmedica Osteonics Corp. Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241
Product Usage:
Intended for fixation of fractures, joint contractures, fusions, limb Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.