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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 K993630
Device Name BIOLOK SCREW
Applicant
Encore Orthopedics, Inc.
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact DEBBIE DE LOS SANTOS
Correspondent
Encore Orthopedics, Inc.
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact DEBBIE DE LOS SANTOS
Regulation Number888.3040
Classification Product Code
HWC  
Date Received10/27/1999
Decision Date 04/26/2000
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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