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Recognized Consensus Standards
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Recognition List Number: 030 Publication Date: 01/15/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 11-246: ASTM F1717-12, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. (Orthopaedics)

Date of Standard: 2012. 
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:
This standard contains test methods for spinal implant assemblies in a vertebrectomy model. Devices commonly tested using the methods described in this standard include: pedicle and/or lateral mass screw systems, hook systems, and anterior and lateral plating systems.
Processes Affected:
510(k), IDE, PMA, HDE
Type of Standard:
 International, Test Methods, Vertical
Extent of Recognition:
Complete Standard.

This standard describes static and fatigue test methods for spinal implants in a vertebrectomy model. The methods described may not be sufficient to characterize all mechanical aspects of the device being tested.
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
Unclassified Orthosis, Cervical Pedicle Screw Spinal Fixation Class U NKG
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§888.3050 Appliance, Fixation, Spinal Interlaminal Class 2 KWP
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§888.3060 Appliance, Fixation, Spinal Intervertebral Body Class 2 KWQ
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§888.3070 Orthosis, Spinal Pedicle Fixation Class 2 MNI
§888.3070 Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease Class 3 NKB
§888.3070 Orthosis, Spondylolisthesis Spinal Fixation Class 2 MNH
 
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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