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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 K250603
Device Name AxTiHA® Stand-Alone ALIF System
Applicant
Innovasis
614 E 3900 S
Salt Lake City,  UT  84107
Applicant Contact Mr. Mike Thomas
Correspondent
Innovasis
614 E 3900 S
Salt Lake City,  UT  84107
Correspondent Contact Mr. Mike Thomas
Regulation Number888.3080
Classification Product Code
OVD  
Date Received02/28/2025
Decision Date 03/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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