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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K032752
Device Name R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM
Applicant
R&B SURGICAL SOLUTIONS, LLC.
8202 SHERMAN ROAD
CHESTERLAND,  OH  44026
Applicant Contact KAREN E WARDEN
Correspondent
R&B SURGICAL SOLUTIONS, LLC.
8202 SHERMAN ROAD
CHESTERLAND,  OH  44026
Correspondent Contact KAREN E WARDEN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/05/2003
Decision Date 12/03/2003
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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