INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
FDA 510(k) clearance K063124 · decided 2007-01-19
Clearance details
- K-number
- K063124
- Device name
- INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-13
- Decision date
- 2007-01-19
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Plainsboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed recall (Z-1795-2012) | Integra LifeSciences Corp. | 2012-06-12 |