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Recognized Consensus Standards
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Recognition List Number: 025 Publication Date: 10/04/2010 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 11-224: ASTM F2706-08, Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebretomy Model. (Orthopaedics)

Date of Standard: 2008. 
Address of Standards Organization:
  ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Spinal implant constructs intended for posterior occipital-cervical or occipital-cervical-thoracic fixation to the spine
Processes Affected:
510(k), PMA, IDE, PDP, Design Controls
Type of Standard:
 Vertical, International, Test Methods
Extent of Recognition:
Complete standard.

Test methods provide examples of acceptable types of static and fatgue test methods for the characterization of spinal implant constructs intended for posterior occipital-cervical or occipital-cervical-thoracic fixation to the spine. Additional information should be provided to document that the design of the product will provide adequate mechanical properties for the particular application. In applications subjected to wear or articulation, additional data should be provided to document resistance to wear and abrasion. This standard may not address all aspects of testing of dynamic statbilization systems.
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§888.3050 Appliance, Fixation, Spinal Interlaminal Class 2 KWP
 
Relevant Guidance:
Guidance for Industry and FDA Staff - Spinal System 510(k)s, May 3, 2004

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/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1418
  Silver Spring MD 20993
  301/796-5650
  Email: jonathan.peck@fda.hhs.gov
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