FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTEON UNIPOLAR
K Number: K960538
·
Decision Mar 27, 1996
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
106
Applicant Total
186
Review Days
49
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Basic Information
- Device Name
- OPTEON UNIPOLAR
- K Number
- K960538
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exactech, Inc.
- Date Received
- February 7, 1996
- Decision Date
- March 27, 1996
- 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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