510(k) K001353 ยท HBW Fastener, Plate, Cranioplasty
MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM
| Applicant | Biomedical Ent., Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Mar 13, 2001 |
| Received | Apr 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001353
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.