510(k) K081501 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
SOLITAIRE ANTERIOR SPINAL SYSTEM
| Applicant | Biomet Spine, Parsippany NJ, US |
| Decision | Substantially Equivalent, Jul 2, 2008 |
| Received | May 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081501
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 12, 2016 | Biomet Spine, LLC 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230.
Product Usage:
The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for s Terminated |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.