Product Classification

• Device: intervertebral fusion device with bone graft, thoracic
• Regulation Description: Intervertebral body fusion device.
• Definition: Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
• Physical State: hollow cylinder or rectangular box made of metal or polymer
• Technical Method: Acts as a disc spacer and holds bone graft.
• Target Area: intervertebral disc space
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: PHM
• Premarket Review: Office of Orthopedic Devices (OHT6); Spinal Devices (DHT6B)
• Submission Type: 510(k)
• Regulation Number: 888.3080
• 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

• 11-390 ISO 23089-2 First edition 2021-05
  Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices

Third Party Review

Not Third Party Eligible