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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K931665
Device Name 6.5 MM CANCELLOUS BONE SCREW
Applicant
Encore Orthopedics, Inc.
8920 Business Park Dr.
Sutie 380
Austin,  TX  78759
Applicant Contact WEBB
Correspondent
Encore Orthopedics, Inc.
8920 Business Park Dr.
Sutie 380
Austin,  TX  78759
Correspondent Contact WEBB
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/05/1993
Decision Date 02/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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