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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 K222004
Device Name INTEGRATE -C Interbody Fusion System
Applicant
Happe Spine
220 Lyon St., NW, Suite 500
Grand Rapids,  MI  49503
Applicant Contact Jenna Hollern
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith Lee May
Regulation Number888.3080
Classification Product Code
ODP  
Date Received07/07/2022
Decision Date 04/28/2023
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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