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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 K250335
Device Name IVA & AEON Cervical and Lumbar Cage System
Applicant
K&J Consulting
2260 Glenview Dr.
Lansdale,  PA  19446
Applicant Contact Milan George
Correspondent
K&J Consulting
2260 Glenview Dr.
Lansdale,  PA  19446
Correspondent Contact Milan George
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MAX   OVD   OVE  
Date Received02/05/2025
Decision Date 08/29/2025
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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