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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 Intervertebral Body
510(k) Number K061353
Device Name TRINICA ANTERIOR LUMBAR PLATE SYSTEM
Applicant
Zimmer Spine, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Applicant Contact TIM CRABTREE
Correspondent
Zimmer Spine, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Correspondent Contact TIM CRABTREE
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received05/15/2006
Decision Date 08/30/2006
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
Recalls CDRH Recalls
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