510(k) K063205 ยท MQP Spinal Vertebral Body Replacement Device
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
| Applicant | Atlas Spine, LLC, San Diego CA, US |
| Decision | Substantially Equivalent, Feb 26, 2007 |
| Received | Oct 23, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063205
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2013 | Atlas Spine, Inc. Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000
Used to rotate implant into position Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.