FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN.
K Number: K910664
·
Decision Apr 1, 1992
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
80
Applicant Total
4
Review Days
412
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Basic Information
- Device Name
- MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN.
- K Number
- K910664
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Medimix Products, Inc.
- Date Received
- February 14, 1991
- Decision Date
- April 1, 1992
- 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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