FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOORE HIP PROSTHESIS, PMMA COATED
K Number: K811416
·
Decision Aug 12, 1981
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
103
Applicant Total
308
Review Days
85
Basic Information
- Device Name
- MOORE HIP PROSTHESIS, PMMA COATED
- K Number
- K811416
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- ZIMMER, INC.
- Date Received
- May 19, 1981
- Decision Date
- August 12, 1981
- Product Code
- KWL
- 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 |
|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | FDA class 2 | Orthopedic |
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