510(k) K113327 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
| Applicant | Stryker Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Mar 29, 2012 |
| Received | Nov 10, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113327
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2018 | Stryker GmbH Hinge Coupling Hoffmann LRF Catalog # 4933-0-800
Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediat Terminated |
KTT | None listed |
| Jan 17, 2013 | Stryker Howmedica Osteonics Corp. Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003. Terminated |
KTT | None listed |
| Nov 8, 2012 | Stryker Howmedica Osteonics Corp. Hoffman LRF Telescopic Strut Short
Stryker
Stryker Trauma AG
CH-2545 Seizach
Distributed in the USA by
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The use of external devices pro Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.