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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 K223043
Device Name The Integrity Spine Core System
Applicant
Integrity Spine
414 W Sunset Rd. 205
San Antonio,  TX  78209
Applicant Contact Timothy Leak
Correspondent
Jalex Medical, LLC
27865 Clemens Rd.
Suite 3
Westlake,  OH  44145
Correspondent Contact Jennifer Palinchik
Regulation Number888.3080
Classification Product Code
ODP  
Date Received09/22/2022
Decision Date 03/20/2023
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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