510(k) K013558 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
| Applicant | Blackstone Medical, Inc., Springfield MA, US |
| Decision | Substantially Equivalent, Jan 23, 2002 |
| Received | Oct 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013558
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.