FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MARK I TOTAL KNEE SYS. ARTHROPLASTY
K Number: K832302
·
Decision Aug 16, 1983
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
13
Applicant Total
22
Review Days
33
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Basic Information
- Device Name
- MARK I TOTAL KNEE SYS. ARTHROPLASTY
- K Number
- K832302
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Advanced Biosearch Assn.
- Date Received
- July 14, 1983
- Decision Date
- August 16, 1983
- Product Code
- MBV
- 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 |
|---|---|---|---|
| MBV | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
FDA 510(k)
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