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HHS/FDA RIN: 0910-AI00 Publication ID: Fall 2018 
Title: Classification of Posterior Cervical Screw Systems 
Abstract:

This final rule will classify an unclassified preamendments device into class II with special controls. A posterior cervical screw system is a device used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion surgery. 

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Other 
CFR Citation: 21 CFR 888   
Legal Authority: 21 U.S.C. 351    21 U.S.C. 360    21 U.S.C. 360c    21 U.S.C. 360e    21 U.S.C. 360j    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/10/2016  81 FR 12607   
NPRM Comment Period End  06/08/2016 
Final Rule  03/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Laurie Sternberg
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-630), 10903 New Hampshire Avenue, Building 66, Room 5517,
Silver Spring, MD 20993
Phone:240 402-0425
Email: laurie.sternberg@fda.hhs.gov