FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NELSON RESURFACING HEAD
K Number: K983452
·
Decision Dec 3, 1998
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
22
Applicant Total
441
Review Days
64
Basic Information
- Device Name
- NELSON RESURFACING HEAD
- K Number
- K983452
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3400
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet, Inc.
- Date Received
- September 30, 1998
- Decision Date
- December 3, 1998
- Product Code
- KXA
- 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 |
|---|---|---|---|
| KXA | Prosthesis, Hip, Femoral, Resurfacing | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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CONSERVE FEMORAL RESURFACING COMPONENT
FDA 510(k)
FDA Class 2
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