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510(k) K121308

HIP SYSTEMS by Howmedica Osteonics Corp. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2012
Date Received
May 1, 2012
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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