FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HIP PROSTHESIS -VARIOUS
K Number: K831420
·
Decision Sep 20, 1983
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
106
Applicant Total
3
Review Days
140
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Basic Information
- Device Name
- HIP PROSTHESIS -VARIOUS
- K Number
- K831420
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- The Oec Group
- Date Received
- May 3, 1983
- Decision Date
- September 20, 1983
- 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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