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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 K201145
Device Name X-Pac Expandable Lumbar Cage System
Applicant
Expanding Innovations, Inc.
110 Pioneer Way, Suite I
Mountain View,  CA  94041
Applicant Contact Mbithi Muthini
Correspondent
Lince Consulting, LLC
111 Deerwood Road, Suite 200
San Ramon,  CA  95483
Correspondent Contact Nancy Lince
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/29/2020
Decision Date 09/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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