Modified Bencox Hip System
FDA 510(k) clearance K150007 · decided 2015-05-04
Clearance details
- K-number
- K150007
- Device name
- Modified Bencox Hip System
- Applicant
- Corentec Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-01-02
- Decision date
- 2015-05-04
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Cheonan-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.