510(k) K072426 ยท NKB Thoracolumbosacral Pedicle Screw System
ATLAS SPINE PEDICLE SCREW SYSTEM
| Applicant | Atlas Spine, LLC, Jupiter FL, US |
| Decision | Substantially Equivalent, Oct 19, 2007 |
| Received | Aug 29, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072426
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2012 | Atlas Spine, Inc. Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1 Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.