510(k) K082754 ยท HSB Rod, Fixation, Intramedullary And Accessories
AEQUALIS HUMERAL NAIL SYSTEM
| Applicant | Tornier, Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 27, 2009 |
| Received | Sep 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082754
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2018 | Tornier, Inc AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140
Product Usage:
The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures o Terminated |
HTW | None listed |
| Jul 29, 2015 | Tornier, Inc Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.