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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 K032830
Device Name PLLA CANNULATED INTERFERENCE SCREW
Applicant
Advanced Biomaterials
504 Mccormick Dr.
Suite T
Glen Burnie,  MD  21061
Applicant Contact STEVE JANIN
Correspondent
Advanced Biomaterials
504 Mccormick Dr.
Suite T
Glen Burnie,  MD  21061
Correspondent Contact STEVE JANIN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/11/2003
Decision Date 12/14/2004
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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