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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K091190
Device Name UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
Applicant
Zimmer Spine, Inc.
5301 Riata Park Court
Bldg. F
Austin,  TX  78727
Applicant Contact HEATHER CRAWFORD
Correspondent
Zimmer Spine, Inc.
5301 Riata Park Court
Bldg. F
Austin,  TX  78727
Correspondent Contact HEATHER CRAWFORD
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received04/23/2009
Decision Date 07/30/2009
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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