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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
Recalls CDRH Recalls
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