510(k) K020245 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
MODIFICATION TO ISOBAR SPINAL SYSTEM
| Applicant | Scien'Tx USA, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Feb 1, 2002 |
| Received | Jan 24, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K020245
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.