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510(k) K100761

BIOPRO POLAR HEAD by Biopro, Inc. — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2010
Date Received
March 17, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

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  • K081149 — BIOPRO GO-EZ SCREW (August 5, 2008)

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