FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION
K Number: K902538
·
Decision Jul 6, 1990
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
90
Applicant Total
74
Review Days
30
Basic Information
- Device Name
- WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION
- K Number
- K902538
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3530
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- DOW CORNING WRIGHT
- Date Received
- June 6, 1990
- Decision Date
- July 6, 1990
- 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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| K930188 | ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT | Aug 3, 1993 | Substantially Equivalent |
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