Clearance Summary
BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP received FDA 510(k) clearance under submission number K112019, sponsored by Corentec Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-10-12.
- Submission: K112019
- Applicant / Sponsor: Corentec Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3390
- Decision date: 2011-10-12
Classification & Regulation
This clearance is catalogued under FDA product code KWY and 21 CFR 888.3390, within the Orthopedic review panel as a Class II device.