FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDACTA BIPOLAR HEAD
K Number: K091967
·
Decision Mar 2, 2010
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
98
Applicant Total
165
Review Days
244
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Basic Information
- Device Name
- MEDACTA BIPOLAR HEAD
- K Number
- K091967
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3390
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta International S.A.
- Date Received
- July 1, 2009
- Decision Date
- March 2, 2010
- 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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