FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IOI METAL BACKED TIBIAL COMPONENT
K Number: K821341
·
Decision Jun 3, 1982
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
90
Applicant Total
108
Review Days
29
Basic Information
- Device Name
- IOI METAL BACKED TIBIAL COMPONENT
- K Number
- K821341
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3530
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- INTERMEDICS ORTHOPEDICS
- Date Received
- May 5, 1982
- Decision Date
- June 3, 1982
- Product Code
- HRY
- 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 |
|---|---|---|---|
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
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