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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 11-203: ASTM F1541-02 (Reapproved 2013), standard specification and test methods for external skeletal fixation devices. (Orthopaedics)

Date of Standard: 2002. 
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:
External skeletal fixation devices
Processes Affected:
510(k), IDE, HDE, PMA, PDP, Design Controls
Type of Standard:
 International, Test Methods, Vertical
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Class 2 KTT
§888.3040 Pin, Fixation, Smooth Class 2 HTY
§888.3040 Pin, Fixation, Threaded Class 2 JDW
Relevant Guidance:
Reviewers Guidance Checklist for Orthopedic External Fixation Devices Version #5, 2/21/97
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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