FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS
K Number: K111481
·
Decision Feb 6, 2012
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
4
Applicant Total
57
Review Days
255
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Basic Information
- Device Name
- CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS
- K Number
- K111481
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corin USA
- Date Received
- May 27, 2011
- Decision Date
- February 6, 2012
- Product Code
- OQI
- 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 |
|---|---|---|---|
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | FDA class 2 | Orthopedic |
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