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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 K000634
Device Name ROD TO ROD CROSS BRACES
Applicant
CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
TAMPA,  FL  33612
Applicant Contact JOEL BATTS
Correspondent
CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
TAMPA,  FL  33612
Correspondent Contact JOEL BATTS
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Codes
KWP   MNH  
Date Received02/25/2000
Decision Date 03/10/2000
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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