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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K192354
Device Name Innovasis Gibralt Spine System
Applicant
Innovasis, Inc.
614 E 3900 S
Salt Lake City,  UT  84107
Applicant Contact Marshall McCarthy
Correspondent
Innovasis, Inc.
614 E 3900 S
Salt Lake City,  UT  84107
Correspondent Contact Marshall McCarthy
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received08/29/2019
Decision Date 09/24/2019
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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