510(k) K063124 ยท MQV Filler, Bone Void, Calcium Compound
INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
| Applicant | Integra Lifesciences Corp., Plainsboro NJ, US |
| Decision | Substantially Equivalent, Jan 19, 2007 |
| Received | Oct 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2012 | Integra LifeSciences Corp. Integra Mozaik Strip
10 cc
Product Usage:
The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.