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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 Interlaminal
510(k) Number K002082
Device Name SPEEDLINK TRANSVERSE CONNECTOR
Applicant
SPINAL CONCEPTS, INC.
12012 TECHNOLOGY BLVD., #100
AUSTIN,  TX  78727
Applicant Contact DAVID M HOOPER
Correspondent
SPINAL CONCEPTS, INC.
12012 TECHNOLOGY BLVD., #100
AUSTIN,  TX  78727
Correspondent Contact DAVID M HOOPER
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received07/10/2000
Decision Date 10/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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