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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 K062505
Device Name NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX 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
KWP  
Date Received08/28/2006
Decision Date 09/26/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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