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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 K200958
Device Name MODULIF-A Anterior Lumbar Interbody Fusion System
Applicant
Spinal Stability, LLC
104 Hensley Circle
Austin,  TX  78738
Applicant Contact David Krueger
Correspondent
The OrthoMedix Group, Inc.
4313 W. 3800 S.
West Heven,  UT  84401
Correspondent Contact J.D. Webb
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/10/2020
Decision Date 08/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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