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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 K203327
Device Name VERTACONNECT TLIF Cage
Applicant
SIGNUS Medizintechnik
Industriestrasse 2
Alzenau,  DE 63755
Applicant Contact Antje Schmidt
Correspondent
The OrthoMedix Group, Inc.
4313 W. 3800 S.
West Haven,  UT  84401
Correspondent Contact J.D. Webb
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/12/2020
Decision Date 01/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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