510(k) K013447 ยท KWP Appliance, Fixation, Spinal Interlaminal
ISOBAR SPINAL SYSTEM
| Applicant | Scien'Tx USA, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jan 15, 2002 |
| Received | Oct 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013447
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.