510(k) K112019
K112019 is an FDA 510(k) premarket notification submitted by Corentec Co., Ltd. for the device "BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP". The FDA issued a decision of Substantially Equivalent on Oct 12, 2011. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. Corentec Co., Ltd. has 32 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 12, 2011
- Date Received
- Jul 14, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3390
- Review Panel
- OR
- Submission Type
- 510(k)