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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Metal/Polymer Spinal System, Fusion
510(k) Number K092234
Device Name DYNESYS TOP-LOADING SPINAL SYSTEM
Applicant
Zimmer Spine, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Applicant Contact ELSA A LINKE
Correspondent
Zimmer Spine, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Correspondent Contact ELSA A LINKE
Regulation Number888.3070
Classification Product Code
NQP  
Date Received07/23/2009
Decision Date 10/01/2009
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
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