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510(k) K151264

Restoration Anatomic Shell by Stryker Orthopaedics — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2015
Date Received
May 13, 2015
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

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