• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 11-75: ISO 5838-3 First edition 1993-09-15, implants for surgery -- skeletal pins and wires -- part 3: kirschner skeletal wires. (Orthopedic )

Date of Standard: 1993. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
Smooth or threaded fixation pins and wires used with or without external skeletal fixation devices.
Processes Affected:
510(K), Design Controls
Type of Standard:
 International, Vertical, Test Methods
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Device Name Device
§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, 2/21/97
FDA Technical Contact:
 Jonathan Peck
  10903 New Hampshire Avenue WO66 RM1418
  Silver Spring MD 20993
  email: jonathan.peck@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036