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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Recognition 07/09/2014 
FR Recognition Number 11-276
Standard
ASTM F1798-13
Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
Scope/Abstract
1.1 This test method covers the measurement of uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants.

1.2 The purpose of this test method is to provide a means of mechanically characterizing different designs of spinal implant interconnections. Ultimately, the various components and interconnections should be combined for static and fatigue testing of the spinal implant construct. It is not the intention of this test method to address the analysis of spinal implant constructs or subconstructs or to define levels of performance of spinal implants as insufficient knowledge is available to predict the consequences of the use of particular spinal implant designs.

1.3 This test method sets out definitions for use in measuring the strength of component interconnections of spinal implants, possible test methods themselves, and the reporting of test results.

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
PEDICLE SCREW SPINAL SYSTEM
§888.3070 Orthosis, Spinal Pedicle Fixation Class 2 MNI
§888.3070 Orthosis, Spondylolisthesis Spinal Fixation Class 2 MNH
§888.3060 Appliance, Fixation, Spinal Intervertebral Body Class 2 KWQ
§888.3050 Appliance, Fixation, Spinal Interlaminal Class 2 KWP
IDE
Unclassified Spinal Pedicle Screw, Fixation, Appliance System Class 3 MCV
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and/or FDA Reviewers/Staff - Guidance Document for the Preparation of IDEs for Spinal Systems, January 13, 2000
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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