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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 K203531
Device Name XYPAN Expandable Lumbar Cage System
Applicant
Aegis Spine, Inc.
9781 S. Meridian Blvd, Ste 300
Englewood,  CO  80112
Applicant Contact Woo Joong Kwon
Correspondent
Empirical Testing Corp.
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Meredith Lee May
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/02/2020
Decision Date 01/29/2021
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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