Product Classification

• Device: condylar plate fixation implant
• Regulation Description: Single/multiple component metallic bone fixation appliances and accessories.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: JDP
• Submission Type: 510(k)
• Regulation Number: 888.3030
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ASTM F 897-02 (Reapproved 2007) Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
• ASTM F 983-86 (Reapproved 2009) Standard Practice for Permanent Marking of Orthopaedic Implant Components
• ASTM F 565-04 (Reapproved 2009)e1 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• ASTM F 382-99 (Reapproved 2008)e1 Standard Specification and Test Method for Metallic Bone Plates
• ASTM F382-99 (Reapproved 2008) Standard Specification and Test Method for Metallic Bone Plates
• ASTM F 2026-10 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

Third Party Review

Not Third Party Eligible