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510(k) K110807

ABG II MONOLITHIC HIP STEM by Stryker Corp. — Product Code MAY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2011
Date Received
March 23, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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