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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spinal pedicle fixation
510(k) Number K071880
Device Name Optima ZS Transition Screw
Applicant
ZIMMER SPINE, INC
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55441
Applicant Contact NICOLE BOWDEN
Correspondent
ZIMMER SPINE, INC
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55441
Correspondent Contact Nicole Bowden
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received07/09/2007
Decision Date 10/05/2007
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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