FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
K Number: K063124
·
Decision Jan 19, 2007
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
29
Review Days
98
Basic Information
- Device Name
- INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
- K Number
- K063124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra Lifesciences Corp.
- Date Received
- October 13, 2006
- Decision Date
- January 19, 2007
- Product Code
- MQV
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | FDA class 2 | Orthopedic |
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