Orthopedic 17
- Technical Considerations for Non-Spinal Metallic and Polymer Bone Plates and Screws
- Class II Non-Spinal Metallic Bone Screws and Washers - Safety and Performance Based Pathway
- Orthopedic Device Metallic and Calcium Phosphate Coatings: Testing and Characterization Requirements (DRAFT)
- Patient-Matched Orthopedic Surgical Guides: Testing, Documentation and Safety Requirements (DRAFT)
- Multiple Patient Use Arthroscopy Pump Tubing Sets - Safety, Testing and Labeling Requirements
- Spinal Plating Systems - Safety and Performance Based Testing for Anterior Cervical and Anterior/Lateral Thoracolumbar Devices
- Classification and Special Controls for Posterior Cervical Screw Systems
- Bone Anchors (Suture Anchors) for Appendicular Skeleton - Content and Testing Requirements for 510k Submissions
- Testing and Characterization of Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices
- 510k Exemption for Unclassified Medical Devices in Selected Product Categories
- Technical Considerations for Additive Manufactured Medical Devices
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- Procedures for Medical Devices Advisory Committee Panel Meetings
- Use of Real-World Data to Generate Evidence for Medical Device Regulatory Decisions
- Assessment of Radiofrequency-Induced Heating in Multi-Configuration Passive Medical Devices for MR Conditional Labeling
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Total Artificial Disc Devices - Pre-clinical Testing and Clinical Trial Design Requirements