FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SYNTHACER; SYNTRICER
K Number: K041177
·
Decision Jun 23, 2005
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
1
Review Days
414
Basic Information
- Device Name
- SYNTHACER; SYNTRICER
- K Number
- K041177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medartis Medizinprodukte Und Forschung AG
- Date Received
- May 5, 2004
- Decision Date
- June 23, 2005
- 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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