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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, Intraosseous
510(k) Number K993493
Device Name THE AUTOTAC SYSTEM
Applicant
BioHorizons Implant Systems, Inc.
One Perimeter Park S.
Suite 230, S.
Birmingham,  AL  35243
Applicant Contact WINSTON D GREER
Correspondent
BioHorizons Implant Systems, Inc.
One Perimeter Park S.
Suite 230, S.
Birmingham,  AL  35243
Correspondent Contact WINSTON D GREER
Regulation Number872.4880
Classification Product Code
DZL  
Date Received10/15/1999
Decision Date 01/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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