Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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047
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Date of Entry 08/21/2017
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FR Recognition Number
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8-449
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Standard | |
ASTM F1058-16 Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008) |
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Scope/Abstract1.1 This specification covers the chemical, mechanical, and metallurgical requirements for two grades of wrought 40cobalt-20chromium-16iron-15nickel-7molybdenum alloy in the form of wire, strip and bar used for the manufacture of surgical implants. |
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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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Public Law, CFR Citation(s) and Procode(s)*
Implantable Medical Devices |
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Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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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. |