510(k) K163656 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Hoffmann LRF System
| Applicant | Stryker GmbH, Mahwah NJ, US |
| Decision | Substantially Equivalent, Apr 14, 2017 |
| Received | Dec 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163656
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2018 | Stryker GmbH Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: O Terminated |
KTT | None listed |
| Aug 28, 2018 | Stryker GmbH Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Terminated |
KTT | None listed |
| Aug 28, 2018 | Stryker GmbH Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Terminated |
KTT | None listed |
| Aug 28, 2018 | Stryker GmbH Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Terminated |
KTT | None listed |
| Jul 26, 2018 | Stryker GmbH Hoffmann LRF Hexapod Software
Catalog #: 983031
Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002 Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.