Product Classification

• Device: spinal vertebral body replacement device - cervical
• Regulation Description: Spinal intervertebral body fixation orthosis.
• Definition: Vertebral body replacement in the cervical spine.
• Physical State: Metallic or polymeric device (usually rectangular or cylindrical), with open central and lateral canals for bone graft containment, providing rigidity and structural support.
• Technical Method: Provides structural support for the indicated population.
• Target Area: Cervical spine
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: PLR
• Premarket Review: Spinal Devices (DHT6B); 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 Standard

• 11-423 ASTM F2267-24
  Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

Guidance Document

• Spinal System 510(k)s - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible