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510(k) K103104

SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT by Howmedica Osteonics Corp. — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2010
Date Received
October 20, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

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