FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM
K Number: K941534
·
Decision Mar 6, 1995
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
98
Applicant Total
49
Review Days
341
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Basic Information
- Device Name
- MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM
- K Number
- K941534
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3390
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Health Care, Ltd.
- Date Received
- March 30, 1994
- Decision Date
- March 6, 1995
- Product Code
- KWY
- 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 |
|---|---|---|---|
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K932307 | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM | Jan 7, 1994 | Substantially Equivalent |
| K932422 | 3M TEGADERM HP TRANSPARENT DRESSING | Dec 27, 1993 | Substantially Equivalent |
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| K933006 | AVI INFUSION PUMPS, ADDITIONAL INTENDED USE | Oct 25, 1993 | Substantially Equivalent |
| K933005 | AVI MODEL 600 SYRINGE PUMP | Oct 25, 1993 | Substantially Equivalent |