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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 K062785
Device Name LTD POLYAXIAL FIXATION SYSTEM
Applicant
Us Spine
13540 Guild Ave.
Apple Valley,  MN  55124
Applicant Contact RICHARD JANSEN
Correspondent
Us Spine
13540 Guild Ave.
Apple Valley,  MN  55124
Correspondent Contact RICHARD JANSEN
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received09/18/2006
Decision Date 12/26/2006
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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