510(k) K111439 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
CHESAPEAKE (CERVICAL COMPONENTS)
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Aug 24, 2011 |
| Received | May 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111439
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2021 | K2M, Inc Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine)
Catalog number: 3608-90033 Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.