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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 K162143
Device Name FixxSure® X-Link
Applicant
Innovasis, Inc.
614 E 3900 S
Salt Lake City,  UT  84107
Applicant Contact MARSHALL MCCARTY
Correspondent
Innovasis, Inc.
614 E 3900 S
Salt Lake City,  UT  84107
Correspondent Contact MARSHALL MCCARTY
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received08/01/2016
Decision Date 09/23/2016
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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