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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 K022374
Device Name CADENCE SPINAL FIXATION SYSTEM
Applicant
Sulzer Spine-Tech
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Applicant Contact KRISTYN M BENSON
Correspondent
Sulzer Spine-Tech
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Correspondent Contact KRISTYN M BENSON
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received07/22/2002
Decision Date 09/24/2002
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
Recalls CDRH Recalls
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