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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 11-266: ASTM F2665-09, standard specification for total ankle replacement prosthesis. (Orthopaedics)

Date of Standard: 2009. 
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:
Total Ankle Prostheses
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Controls
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Prosthesis, Ankle, Uncemented, Non-Constrained Class 3 NTG
§888.3100 Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite Class 2 KMD
§888.3110 Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Class 2 HSN
§888.3120 Prosthesis, Ankle, Cemented, Non-Constrained Class 3 KXC
FDA Technical Contact:
 John Goode
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1510
  Silver Spring MD 20993
  301/796-6407
  email: john.goode@fda.hhs.gov
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