Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K192494
Device Name NexGen Anterior Cervical Plate System
Applicant
Precision Spine
2050 Executive Drive
Pearl,  MS  39208
Applicant Contact Michael C. Dawson
Correspondent
The OrthoMedix Group, Inc.
4313 W. 3800 S.
West Haven,  UT  84401
Correspondent Contact J. D. Webb
Regulation Number888.3060
Classification Product Code
KWQ  
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
-
-