510(k) K143085
Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach by
Stryker Orthopaedics
— Product Code LPH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2015
- Date Received
- October 27, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3358
- Review Panel
- OR
- Submission Type