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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 K211740
Device Name DualX
Applicant
Amplify Surgical, Inc.
9272 Jeronimo Rd Suite 107B
Irvine,  CA  92618
Applicant Contact Andy Choi
Correspondent
Empirical Testing Corp.
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Meredith May
Regulation Number888.3080
Classification Product Code
MAX  
Date Received06/07/2021
Decision Date 09/29/2021
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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