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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 K052566
Device Name NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY
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 Received09/19/2005
Decision Date 01/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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