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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, Cervical
510(k) Number K221138
Device Name Titus Titanium Cervical by SAGICO
Applicant
Sagico VA USA, LLC
2189 W.Busch Blvd.
Tampa,  FL  33612
Applicant Contact James Gibson
Correspondent
Sagico VA USA, LLC
2189 W.Busch Blvd.
Tampa,  FL  33612
Correspondent Contact James Gibson
Regulation Number888.3080
Classification Product Code
OVE  
Date Received04/19/2022
Decision Date 08/04/2023
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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