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510(k) K122382

DYNASTY BIOFOAM SHELL by Wrightmedicaltechnologyinc — Product Code MBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2012
Date Received
August 6, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

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