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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 K220655
Device Name X-Pac Expandable Lumbar Cage System
Applicant
Expanding Innovations, Inc
110 Pioneer Way, Ste 1
Mountain View,  CA  94041 -1519
Applicant Contact Robert Jaramillo
Correspondent
Kapstone Medical, LLC
510 Elliot Street
Charlotte,  NC  28202
Correspondent Contact Carolyn Guthrie
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/07/2022
Decision Date 03/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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