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510(k) K960534

METALLIC SPHERICAL CMC IMPLANT by Wrightmedicaltechnologyinc — Product Code KYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1997
Date Received
February 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Carpal Trapezium
Device Class
Class II
Regulation Number
888.3770
Review Panel
OR
Submission Type

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