Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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058
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Date of Entry 05/30/2022
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FR Recognition Number
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8-585
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Standard | |
ASTM F1377-21 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538) |
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Scope/Abstract1.1 This specification covers the requirements for cobalt-28chromium-6molybdenum alloy powders for use in fabricating cobalt-28chromium-6molybdenum alloy medical devices.
1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques, or in metal injection molding or additive manufacturing.
1.3 This specification covers powder requirements only. It does not address properties of the coatings or components formed from them. |
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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)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.3640 |
Implant, Endosseous, Root-Form
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Class 2
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DZE
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§872.3940 |
Joint, Temporomandibular, Implant
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Class 3
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LZD
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§872.3950 |
Glenoid Fossa Prosthesis
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Class 3
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MPI
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§872.3960 |
Mandibular Condyle Prosthesis
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Class 3
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MPL
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§888.3358 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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Class 2
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LPH
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§888.3358 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
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Class 2
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MBL
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§888.3565 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
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Class 2
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MBH
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N/A |
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Class 3
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MBD
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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. |
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