510(k) K010378 ยท MQP Spinal Vertebral Body Replacement Device
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
| Applicant | Implex Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Jan 28, 2002 |
| Received | Feb 8, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010378
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.