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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, Lumbar
510(k) Number K223174
Device Name X-Pac Expandable LLIF Cage System
Applicant
Expanding Innovations, Inc.
110 Pioneer Way, Suite 1
Mountain View,  CA  94041 -1519
Applicant Contact Robert Jaramillo
Correspondent
Kapstone Medical, LLC
510 Elliot St.
Charlotte,  NC  28202
Correspondent Contact Carolyn Guthrie
Regulation Number888.3080
Classification Product Code
MAX  
Date Received10/11/2022
Decision Date 02/14/2023
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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