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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K000797
Device Name OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01
Applicant
Orthopaedic Biosystems, Ltd.
15990 N Greenway-Hayden Loop
Suite 100
Scottsdale,  AZ  85260
Applicant Contact MELODY F MARTIN
Correspondent
Orthopaedic Biosystems, Ltd.
15990 N Greenway-Hayden Loop
Suite 100
Scottsdale,  AZ  85260
Correspondent Contact MELODY F MARTIN
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Codes
GAT   MBI  
Date Received03/13/2000
Decision Date 04/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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