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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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09/17/2018 Orthopedic 11-334 Complete ASTM F1829-17 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
12/21/2020 Orthopedic 11-330 Partial ASTM F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
08/21/2017 Orthopedic 11-321 Complete ASTM F2887-17 Standard Specification for Total Elbow Prostheses
06/27/2016 Orthopedic 11-307 Complete ASTM F2385-15 (Reapproved 2019) Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
04/04/2016 Orthopedic 11-303 Complete ASTM F3047M-15 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
04/04/2016 Orthopedic 11-301 Complete ASTM F2091-15 Standard Specification for Acetabular Prostheses
04/04/2016 Orthopedic 11-299 Complete ASTM F2068-15 Standard Specification for Femoral Prostheses - Metallic Implants
08/14/2015 Orthopedic 11-294 Complete ASTM F1357-14 (Reapproved 2019) Standard Specification for Articulating Total Wrist Implants
01/27/2015 Orthopedic 11-281 Complete ASTM F1672-14 (Reapproved 2019) Standard Specification for Resurfacing Patellar Prosthesis
07/09/2014 Orthopedic 11-276 Complete ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
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