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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with integrated fixation, lumbar
510(k) Number K212967
Device Name AxTiHA Stand-Alone ALIF 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 Number888.3080
Classification Product Code
OVD  
Date Received09/16/2021
Decision Date 10/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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