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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 K110197
Device Name EXACTECH GIBRALT SPINAL SYSTEM
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Applicant Contact VLADISLAVA ZAITSEVA
Correspondent
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Correspondent Contact VLADISLAVA ZAITSEVA
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received01/24/2011
Decision Date 07/15/2011
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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