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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 11-329
Standard
ASTM F2180-17
Standard Specification for Metallic Implantable Strands and Cables
Scope/Abstract
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.

Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§888.3010 Bone Fixation Cerclage, Sublaminar Class 2 OWI
§888.3010 Cerclage, Fixation Class 2 JDQ
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance published at this time.
FDA Technical Contacts
 Jonathan Peck
  FDA/OMPT/CDRH/ODE/DOD/PSDB/
  301-796-5650
  jonathan.peck@fda.hhs.gov
 Christopher Ferreira
  FDA/OMPT/CDRH/ODE/DOD/JFDB2/
  301-796-9350
  christopher.ferreira@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
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