Document Detail


Orthopedic devices: classification and reclassification of pedicle screw spinal systems--FDA. Final rule.
MedLine Citation:
PMID:  10181517     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is classifying certain previously unclassified preamendments pedicle screw spinal systems into class II (special controls) and reclassifying certain postamendments pedicle screw spinal systems from class III (premarket approval) to class II. FDA is taking this action because it believes that special controls would provide reasonable assurance of safety and effectiveness. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Authors:
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  63     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  1998 Jul 
Date Detail:
Created Date:  1998-09-03     Completed Date:  1998-09-03     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  40025-41     Citation Subset:  H    
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MeSH Terms
Descriptor/Qualifier:
Device Approval / legislation & jurisprudence*
Equipment and Supplies / classification*
Humans
Orthopedic Fixation Devices / classification,  standards*
Spinal Cord / abnormalities*
Spinal Fusion
United States
United States Food and Drug Administration

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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