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510(k) K102019

RESTORATION ACETABULAR WEDGE AUGMENTS by Howmedica Osteonics — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2011
Date Received
July 19, 2010
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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  • K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (November 1, 2012)
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  • K120578 — ACCOLADE II HIP STEM (March 29, 2012)

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