510(k) K141760 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
ORTHOFIX GALAXY WRIST
| Applicant | Orthofix Srl, Wilmington NC, US |
| Decision | Substantially Equivalent, Dec 8, 2014 |
| Received | Jul 1, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141760
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656 Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.