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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 K031855
Device Name SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM
Applicant
Spinal Concepts, Inc.
5301 Riata Park Ct.
Bldg. F
Austin,  TX  78727
Applicant Contact LISA PETERSON
Correspondent
Spinal Concepts, Inc.
5301 Riata Park Ct.
Bldg. F
Austin,  TX  78727
Correspondent Contact LISA PETERSON
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Codes
KWP   MNH   MNI   NKB  
Date Received06/16/2003
Decision Date 09/17/2003
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
Recalls CDRH Recalls
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