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U.S. Department of Health and Human Services

Recognized Consensus Standards

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

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 Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
CDRH Office and Division associated with recognized standards:
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
Related CFR Citations and Product Codes:
Device Name Device
§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
  10903 New Hampshire Avenue Building 66, Room 1418
  Silver Spring MD 20993
  email: jonathan.peck@fda.hhs.gov