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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 K031985
Device Name SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION 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 Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received06/27/2003
Decision Date 09/11/2003
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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