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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 FR Publication Date 04/04/2016 
FR Recognition Number 11-297
Standard
ASTM F382-14
Standard Specification and Test Method for Metallic Bone Plates
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§888.4540 Bender Class 1 HXW
§888.4540 Instrument, Bending Or Contouring Class 1 HXP
§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 Plate, Fixation, Bone Class 2 HRS
FDA Technical Contact
 Jonathan Peck
  FDA/OMPT/CDRH/ODE/DOD/PSDB/
  301-796-5650
  jonathan.peck@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
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