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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 11-215: ASTM F 897-02 (Reapproved 2013), standard test method for measuring fretting corrosion of osteosynthesis plates and screws. (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:
Applies specifically to osteosynthesis plates and screws, but may also be used to study fretting corrosion of other devices where metal components are in contact.
Processes Affected:
510(K), PMA, IDE, PDP, DESIGN CONTROLS
Type of Standard:
 Test Methods, National, Horizontal
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
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Class 2 LXT
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Class 2 KTW
§888.3030 Appliance, Nail/Blade/Plate Combination, Single Component Class 2 KWK
§888.3030 Condylar Plate Fixation Implant Class 2 JDP
§888.3030 Device, Fixation, Proximal Femoral, Implant Class 2 JDO
§888.3030 Plate, Fixation, Bone Class 2 HRS
§888.3040 Screw, Fixation, Bone Class 2 HWC
Relevant Guidance:
Guidance Document for Testing Non-Articulating, 'Mechanically Locked,' Modular Implant Components, May 1, 1995
FDA Technical Contact:
 Terry O. Woods
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 2116
  Silver Spring MD 20993
  301/796-2503
  email: terry.woods@fda.hhs.gov
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