FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
K Number: K012493
·
Decision Aug 29, 2001
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
560
Applicant Total
146
Review Days
26
Basic Information
- Device Name
- ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
- K Number
- K012493
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EXACTECH, INC.
- Date Received
- August 3, 2001
- Decision Date
- August 29, 2001
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
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