| ASTM F2180-17 Standard Specification for Metallic Implantable Strands and Cables |
| Recognition Number | Orthopedic |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 11-329 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Orthopedic |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
1.1 This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables.
1.2 This specification is intended to assist in the development of specific strand and cable specifications. It is particularly appropriate for high load bearing applications. It is not intended however, to address all of the possible variations in construction, material, or properties.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3010 | Bone Fixation Cerclage, Sublaminar | Class 2 | OWI |
| §888.3010 | Cerclage, Fixation | Class 2 | JDQ |
| There is no relevant guidance published at this time. |