Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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053
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Date of Entry 12/23/2019
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FR Recognition Number
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8-492
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Standard | |
ISO 5832-9 Third edition 2019-02 Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel |
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Scope/AbstractThis document specifies the characteristics of, and corresponding test methods for, wrought stainless steel containing a mass fraction of 0,25 % to 0,50 % nitrogen for use in the manufacture of surgical implants for which high levels of strength and corrosion resistance are required.
NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
NOTE 2 Requirements for other stainless steels for implants for surgery can be found in ISO 5832-1.
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Transition Period
FDA recognition of ISO 5832-9 Second edition 2007-06-15 [Rec# 8-150] will be superseded by recognition of ISO 5832-9 Third edition 2019-02 [Rec# 8-492]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-150] until July 24, 2022. After this transition period, declarations of conformity to [Rec# 8-150] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.4600 |
Lock, Wire, And Ligature, Intraoral |
Class 2 |
DYX |
§872.4760 |
External Mandibular Fixator And/Or Distractor |
Class 2 |
MQN |
§872.4760 |
Implant, Transmandibular |
Class 2 |
MDL |
§872.4760 |
Plate, Bone |
Class 2 |
JEY |
§872.4880 |
Screw, Fixation, Intraosseous |
Class 2 |
DZL |
21 CFR 888.3XXX Metallic components of all implantables |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |