Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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8-123
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Standard | |
ISO 5832-5 Third edition 2005-10-15 Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel alloy |
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Scope/AbstractThis part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought cobalt-chromium-tungsten-nickel alloy for use in the manufacture of surgical implants.
NOTE The tensile properties of a sample obtained from a finished product made of this alloy might not necessarily comply with those specified in this part of ISO 5832. |
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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)*
21 CFR 888.3XXX Metallic components of all implantables |
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.3950 |
Glenoid Fossa Prosthesis |
Class 3 |
MPI |
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.3960 |
Mandibular Condyle Prosthesis |
Class 3 |
MPL |
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.4600 |
Lock, Wire, And Ligature, Intraoral |
Class 2 |
DYX |
Regulation Number |
Device Name |
Device Class |
Product Code |
§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 |
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.3645 |
Implant, Subperiosteal |
Class 2 |
ELE |
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.3940 |
Joint, Temporomandibular, Implant |
Class 3 |
LZD |
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.4880 |
Screw, Fixation, Intraosseous |
Class 2 |
DZL |
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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. |