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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K090060
Device Name NEXLINK OCT SYSTEM, MODEL 7000 SERIES
Applicant
Abbott Spine, Inc.
5301 Riata Park Ct.
Bldg. F
Austin,  TX  78727
Applicant Contact DAVID PADGETT
Correspondent
Abbott Spine, Inc.
5301 Riata Park Ct.
Bldg. F
Austin,  TX  78727
Correspondent Contact DAVID PADGETT
Regulation Number888.3050
Classification Product Code
KWP  
Date Received01/09/2009
Decision Date 06/02/2009
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
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