510(k) K953778 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM
| Applicant | Advanced Spine Fixation Systems, Inc., Cypress CA, US |
| Decision | Substantially Equivalent for Some Indications, Nov 6, 1995 |
| Received | Aug 14, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953778
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.