510(k) K081817 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
ACCELL TBM-R
| Applicant | Isotis Orthobiologics, Inc., Planisboro NJ, US |
| Decision | Substantially Equivalent, Sep 24, 2008 |
| Received | Jun 26, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081817
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.