510(k) K051216 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
HYDRALOK SYSTEM
| Applicant | Altiva Corp., Charlotte NC, US |
| Decision | Substantially Equivalent, Jul 19, 2005 |
| Received | May 12, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051216
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2015 | Exactech, Inc. Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107.
Intended to provide immobilization and stabilization of spinal segments. Terminated |
MNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.