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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 K060634
Device Name NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES
Applicant
ABBOTT SPINE, INC.
5301 RIATA PARK CT., BLDG. F
AUSTIN,  TX  78727
Applicant Contact NOAH BARTSCH
Correspondent
ABBOTT SPINE, INC.
5301 RIATA PARK CT., BLDG. F
AUSTIN,  TX  78727
Correspondent Contact NOAH BARTSCH
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWQ  
Date Received03/09/2006
Decision Date 03/31/2006
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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