FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNIFIT HFX HIP STEM SERIES
K Number: K031744
·
Decision Aug 8, 2003
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
562
Applicant Total
288
Review Days
64
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Basic Information
- Device Name
- OMNIFIT HFX HIP STEM SERIES
- K Number
- K031744
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Howmedica Osteonics Corp.
- Date Received
- June 5, 2003
- Decision Date
- August 8, 2003
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
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