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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K010563
Device Name END-TO-END AND SIDE-BY-SIDE CONNECTORS
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 Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received02/26/2001
Decision Date 05/25/2001
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
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