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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Recognition 06/27/2016 
FR Recognition Number 11-271
Standard
ASTM F2180-02 (Reapproved 2015)
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.
Transition Period
FDA recognition of ASTM F2180-02 [Rec# 11-271] will be superseded by recognition of ASTM F2180-17 [Rec# 11-329]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-271] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 11-271] will not be accepted.
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 developed at this time.
FDA Technical Contact
 Jonathan Peck
  FDA/OMPT/CDRH/ODE/DOD/PSDB/
  301-796-5650
  jonathan.peck@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
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