FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
ALPHA SYSTEM
K Number: K950312
·
Decision May 17, 1995
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
560
Applicant Total
308
Review Days
111
Basic Information
- Device Name
- ALPHA SYSTEM
- K Number
- K950312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- ZIMMER, INC.
- Date Received
- January 26, 1995
- Decision Date
- May 17, 1995
- 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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