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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 Bone Graft, Cervical
510(k) Number K223510
Device Name Matrix HA Fusion Porous Cervical IBF System
Applicant
Innovasis, Inc.
614 E 3900 S
Salt Lake City,  UT  84107
Applicant Contact Michael Thomas
Correspondent
Innovasis, Inc.
614 E 3900 S
Salt Lake City,  UT  84107
Correspondent Contact Michael Thomas
Regulation Number888.3080
Classification Product Code
ODP  
Date Received11/22/2022
Decision Date 12/12/2022
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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