MOZAIK BONE REGENERATION MATRIX - PUTTY
FDA 510(k) clearance K062353 · decided 2006-12-20
Clearance details
- K-number
- K062353
- Device name
- MOZAIK BONE REGENERATION MATRIX - PUTTY
- Applicant
- Integra LifeSciences Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-08-11
- Decision date
- 2006-12-20
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substit recall (Z-1796-2012) | Integra LifeSciences Corp. | 2012-06-12 |
| Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined wi recall (Z-0986-2012) | Integra LifeSciences Corp | 2012-02-08 |
| Integra Mosaik Putty, 15cc, Catalog # PTY10256 Integra Lifesciences, Plainsboro, NJ recall (Z-1034-2009) | Integra LifeSciences Corp | 2009-03-06 |