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
• Premarket Review: Office of Orthopedic Devices (OHT6); Spinal Devices (DHT6B)
• Submission Type: 510(k)
• Regulation Number: 888.3060
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 8-475 ASTM F2026-17
  Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• 8-558 ASTM F3333-20
  Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• 8-574 ASTM F2820-12(2021)e1
  Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
• 8-609 ASTM F2026-23
  Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• 11-185 ASTM F2267-04 (Reapproved 2018)
  Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
• 11-197 ASTM F983-86 (Reapproved 2018)
  Standard Practice for Permanent Marking of Orthopaedic Implant Components
• 11-199 ASTM F565-04 (Reapproved 2018)
  Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• 11-347 ASTM F2077-18
  Test Methods for Intervertebral Body Fusion Devices
• 11-369 ASTM F3292-19
  Standard Practice for Inspection of Spinal Implants Undergoing Testing

Third Party Review

Not Third Party Eligible