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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Wrist, Carpal Trapezium
510(k) Number K960659
Device Name CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
Applicant
Wrightmedicaltechnologyinc
5677 Airline Rd.
Arlington,  TN  38002
Applicant Contact CLIFF R KLINE, II
Correspondent
Wrightmedicaltechnologyinc
5677 Airline Rd.
Arlington,  TN  38002
Correspondent Contact CLIFF R KLINE, II
Regulation Number888.3770
Classification Product Code
KYI  
Date Received02/16/1996
Decision Date 02/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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