510(k) K112592 ยท KWP Appliance, Fixation, Spinal Interlaminal
AXLE PEEK INTERSPINOUS FUSION SYSTEM
| Applicant | X-Spine Systems, Inc., Miamisburg OH, US |
| Decision | Substantially Equivalent, Dec 5, 2011 |
| Received | Sep 7, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112592
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.