510(k) K123991
K123991 is an FDA 510(k) premarket notification submitted by Depuy France S.A.S. for the device "DEPUY CORAIL AMT HIP PROSTHESIS". The FDA issued a decision of Substantially Equivalent on Sep 16, 2013. 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. Depuy France S.A.S. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 16, 2013
- Date Received
- Dec 26, 2012
- 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)