FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
K Number: K120924
·
Decision Sep 10, 2012
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
33
Review Days
167
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Basic Information
- Device Name
- BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
- K Number
- K120924
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corentec Co., Ltd.
- Date Received
- March 27, 2012
- Decision Date
- September 10, 2012
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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