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510(k) K063816

PCA ALUMINA FEMORAL HEADS by Stryker Orthopaedics — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2007
Date Received
December 22, 2006
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, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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