Product Classification

• Device: spinal vertebral body replacement device
• Regulation Description: Spinal intervertebral body fixation orthosis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: MQP
• Submission Type: 510(k)
• Regulation Number: 888.3060
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• 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 F2077-11 Test Methods for Intervertebral Body Fusion Devices
• ASTM F2267-04 (Reapproved 2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
• ASTM F 2026-10 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

Third Party Review

Not Third Party Eligible