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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 11-242: ASTM F1839-08 (Reapproved 2012), standard specification for rigid polyurethane foam for use as a standard material for testing orthopaedic devices and instruments. (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:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Synthetic bone block
Processes Affected:
510(k), IDE, HDE, PMA, PDP, Design Controls
Type of Standard:
 Vertical, National, Test Methods
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§888.3030 Fastener, Fixation, Biodegradable, Soft Tissue Class 2 MAI
§888.3040 Fastener, Fixation, Nondegradable, Soft Tissue Class 2 MBI
§888.3040 Screw, Fixation, Bone Class 2 HWC
§888.3040 Screw, Fixation, Bone, Non-Spinal, Metallic Class 2 NDJ
FDA Technical Contact:
 Michael Kasser
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1576
  Silver Spring MD 20993
  301/796-6946
  email: michael.kasser@fda.hhs.gov
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