FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDO HEAD
K Number: K111145
·
Decision Aug 16, 2011
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
7
Applicant Total
39
Review Days
116
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Basic Information
- Device Name
- ENDO HEAD
- K Number
- K111145
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta International
- Date Received
- April 22, 2011
- Decision Date
- August 16, 2011
- Product Code
- LZY
- 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 |
|---|---|---|---|
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | FDA class 2 | Orthopedic |
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