FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHROME COBALT BALL HEAD
K Number: K962268
·
Decision Oct 23, 1996
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
80
Applicant Total
4
Review Days
132
Basic Information
- Device Name
- CHROME COBALT BALL HEAD
- K Number
- K962268
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ARTOS MEDICAL PRODUCTS GMBH
- Date Received
- June 13, 1996
- Decision Date
- October 23, 1996
- Product Code
- LWJ
- 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 |
|---|---|---|---|
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | FDA class 2 | Orthopedic |
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