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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K192494
Device Name NexGen Anterior Cervical Plate System
Precision Spine
2050 Executive Drive
pearl,  MS  39208
Applicant Contact michael c. dawson
The OrthoMedix Group, Inc.
4313 W. 3800 S.
west haven,  UT  84401
Correspondent Contact j. d. webb
Regulation Number888.3060
Classification Product Code
Date Received09/11/2019
Decision Date 10/29/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No