510(k) K163497
EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt by
Encore Medical, L.P.
— Product Code KWZ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 2017
- Date Received
- December 13, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3310
- Review Panel
- OR
- Submission Type