510(k) K113695 ยท HSB Rod, Fixation, Intramedullary And Accessories
ELLIPSE PRECICE TRAUMA NAIL SYSTEM
| Applicant | Ellipse Technologies, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 28, 2012 |
| Received | Dec 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113695
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2021 | NuVasive Specialized Orthopedics, Inc. NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System:
Model Number/Item Number/Product Description:
CPA1-000 PA0382-001 End Cap
CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM Open, Classified |
HSB | None listed |
| Apr 5, 2021 | Nuvasive Specialized Orthopedics Inc NUVASIVE PRECICE UNYTE System (Humerus and Tibia):
PRECICE Trauma Nail System/PRECICE Unyte-Humerus
Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length;
Orthopedic trauma in Open, Classified |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.