510(k) K080646 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Biomet Spine, Parsippany NJ, US |
| Decision | Substantially Equivalent, May 2, 2008 |
| Received | Mar 6, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080646
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2015 | Biomet Spine, LLC MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization. Terminated |
KWQ | None listed |
| Sep 9, 2015 | Biomet Spine, LLC Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440. Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.