510(k) K053228 ยท MQV Filler, Bone Void, Calcium Compound
THERIGRAFT TCP PUTTY BONE VOID FILLER
| Applicant | Therics, LLC, Princeton NJ, US |
| Decision | Substantially Equivalent, Jan 31, 2006 |
| Received | Nov 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053228
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2010 | Theken Spine Llc Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per b Terminated |
NOX | None listed |
| Sep 18, 2008 | Theken Spine LLC FormPutty Bone Void Filler 10cc
The product is sealed in a foil pouch and then placed in a box following sterilization.
Part # 50-07-0100
Is a flowable resorbable porous bone void filler composed o Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.