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Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 11-185: ASTM F2267-04 (Reapproved 2011), standard test method for measuring load induced subsidence of intervertebral body fusion device under static axial compression. (Orthopedic )

Date of Standard: 2004. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
CDRH Office and Division associated with recognized standards:
Devices Affected:
This standard contains test methods that are potentially relevant to any device that could feasibly subside into a vertebral body. While the scope of the standard is limited to testing of intervertebral body fusion devices, other devices commonly tested using the methods described in this standard include vertebral body replacement devices and total artificial disc replacements.
Processes Affected:
510(k), HDE, IDE, PMA,
Type of Standard:
 Test Methods, National, Vertical
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Device Name Device
Unclassified Prosthesis, Intervertebral Disc Class 3 MJO
§888.3060 Spinal Vertebral Body Replacement Device Class 2 MQP
§888.3080 Intervertebral Fusion Device With Bone Graft, Cervical Class 2 ODP
§888.3080 Intervertebral Fusion Device With Bone Graft, Lumbar Class 2 MAX
§888.3080 Intervertebral Fusion Device With Integrated Fixation, Cervical Class 2 OVE
§888.3080 Intervertebral Fusion Device With Integrated Fixation, Lumbar Class 2 OVD
Relevant Guidance:
Guidance for Industry and FDA Staff - Preparation and Review of Investigational
Device Exemption Applications (IDEs) for Total Artificial Discs, April 11, 2008

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document:
Intervertebral Body Fusion Device, June 12, 2007

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
  10903 New Hampshire Avenue WO66 RM1418
  Silver Spring MD 20993
  email: jonathan.peck@fda.hhs.gov