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HHS/FDA RIN: 0910-AI00 Publication ID: Spring 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: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 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:
Karen Fikes
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301,
Silver Spring, MD 20993
Phone:240 402-7911
Email: karen.fikes@fda.hhs.gov