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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K181063
Device Name Kestrel™ Buttress Plate System
Applicant
Innovasis, Inc.
614 East 3900 South
Salt Lake City,  UT  84107
Applicant Contact Marshall McCarty
Correspondent
Innovasis, Inc.
614 East 3900 South
Salt Lake City,  UT  84107
Correspondent Contact Marshall McCarty
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/23/2018
Decision Date 07/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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