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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 K111301
Device Name INSTINCT JAVA SYSTEM
Applicant
ZIMMER SPINE
7375 BUSH LAKE ROAD
EDINA,  MN  55439
Applicant Contact ELSA A LINKE
Correspondent
ZIMMER SPINE
7375 BUSH LAKE ROAD
EDINA,  MN  55439
Correspondent Contact ELSA A LINKE
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received05/09/2011
Decision Date 08/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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