510(k) K080690 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Theken Spine, LLC, Akron OH, US |
| Decision | Substantially Equivalent, Apr 25, 2008 |
| Received | Mar 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080690
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2011 | Integra LifeSciences Corp. Manta Ray" Anterior Cervical Plate (ACP) System,
Intended use: The Manta Ray ACP System is an anterior cervical plate that is indicated for temporary stabilization of the cervical spine from C2-C7. Terminated |
KWQ | None listed |
| Oct 19, 2010 | Theken Spine Llc Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.