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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 K041925
Device Name ST360 SPINAL FIXATION SYSTEM
Applicant
Zimmer Spine, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Applicant Contact KRISTIN JANS
Correspondent
Zimmer Spine, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Correspondent Contact KRISTIN JANS
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI   NKB  
Date Received07/19/2004
Decision Date 09/24/2004
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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