510(k) K132582 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Feb 12, 2014 |
| Received | Aug 16, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132582
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2016 | Exactech, Inc. Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device.
Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion Terminated |
OVE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.