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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. |
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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 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 |
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Timetable:
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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 |