510(k) K062353 ยท MQV Filler, Bone Void, Calcium Compound
MOZAIK BONE REGENERATION MATRIX - PUTTY
| Applicant | Integra LifeSciences Corporation, Planisboro NJ, US |
| Decision | Substantially Equivalent, Dec 20, 2006 |
| Received | Aug 11, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062353
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2012 | Integra LifeSciences Corp. Integra Mozaik Putty
2.5cc, 5 cc, 10 cc
Product Usage:
The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. T Terminated |
MQV | None listed |
| Feb 8, 2012 | Integra LifeSciences Corp Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal syste Terminated |
MQV | None listed |
| Mar 6, 2009 | Integra LifeSciences Corp Integra Mosaik Putty, 15cc, Catalog # PTY10256
Integra Lifesciences, Plainsboro, NJ Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.