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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K100845
Device Name PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
Applicant
Zimmer Spine, Inc.
5301 Riata Park Ct.
Bldg. F
Austin,  TX  78727
Applicant Contact DAVID PADGETT, RAC (US)
Correspondent
Zimmer Spine, Inc.
5301 Riata Park Ct.
Bldg. F
Austin,  TX  78727
Correspondent Contact DAVID PADGETT, RAC (US)
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received03/25/2010
Decision Date 09/21/2010
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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