510(k) K051781 ยท MQP Spinal Vertebral Body Replacement Device
GRAFTCAGE TLX
| Applicant | Osteotech, Inc., Eatontown NJ, US |
| Decision | Substantially Equivalent, Dec 16, 2005 |
| Received | Jul 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051781
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2012 | Alere San Diego, Inc. Alere Triage BNP PN 98000XR
Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). Terminated |
NBC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.