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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 K013786
Device Name DRG ORTHOHEX SS BONE SCREW
Applicant
Doctor'S Research Group, Inc.
50 Altair Ave.
Plymouth,  CT  06782
Applicant Contact RICHARD DESLAURIERS
Correspondent
Doctor'S Research Group, Inc.
50 Altair Ave.
Plymouth,  CT  06782
Correspondent Contact RICHARD DESLAURIERS
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/14/2001
Decision Date 12/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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