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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K102870
Device Name EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
Applicant
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Applicant Contact VLADISLAVA ZAITSEVA
Correspondent
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Correspondent Contact VLADISLAVA ZAITSEVA
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received09/30/2010
Decision Date 01/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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