FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
GENEX
K Number: K082381
·
Decision Nov 14, 2008
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
27
Review Days
87
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Basic Information
- Device Name
- GENEX
- K Number
- K082381
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biocomposites, Ltd.
- Date Received
- August 19, 2008
- Decision Date
- November 14, 2008
- 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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