| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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041
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Date of Entry 04/04/2016
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FR Recognition Number
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8-399
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| Standard | |
ASTM F90-14
Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) |
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Scope/Abstract| 1.1 This specification covers the requirements for wrought cobalt-20chromium-15tungsten-10nickel alloy used for surgical implants. The properties specified apply specifically to wrought bar, rod, wire, sheet, and strip, but do not apply to surgical fixation wire (see Specification F1091). |
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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| FDA recognition of ASTM F90-14 [Rec# 8-399] will be superseded by recognition of ASTM F90-24 [Rec# 8-630]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-399] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 8-399] will not be accepted. |
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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 Contacts
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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. |
