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HHS/FDA RIN: 0910-AI32 Publication ID: Fall 2022 
Title: Classification of Spinal Spheres For Use in Intervertebral Fusion Procedures 
Abstract:

FDA is classifying spinal spheres for use in intervertebral fusion procedures, an unclassified preamendments device, into class III. FDA believes that there is insufficient information to determine that general controls and special controls would provide reasonable assurance of safety and effectiveness for this device. After considering the recommendations of the Orthopedic and Rehabilitation Devices Panel (Panel held December 12, 2013), FDA is publishing this regulation that will protect and promote the public health by classifying spinal spheres for use in intervertebral fusion procedures.

 
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 
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. 360l    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/15/2021  86 FR 71191   
NPRM Comment Period End  03/15/2022 
Final Rule  03/00/2023 
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:
Madhusoodana Nambiar
Policy Advisor
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 66, Room 5519,
Silver Spring, MD 20993
Phone:301 796-5837
Email: madhusoodana.nambiar@fda.hhs.gov