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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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