510(k) K043522 ยท KWP Appliance, Fixation, Spinal Interlaminal
ISSYS PEDICLE SCREW SYSTEM
| Applicant | Custom Spine, Inc., Conway NH, US |
| Decision | Substantially Equivalent, Jan 14, 2005 |
| Received | Dec 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043522
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.