Product Classification

• Device: prosthetic disc nucleus device
• Definition: Export only
• Physical State: Export Only
• Technical Method: Export Only
• Target Area: Export Only
• Review Panel: Orthopedic
• Product Code: MQO
• Premarket Review: Office of Orthopedic Devices (OHT6); Restorative, Repair and Trauma Devices (DHT6C)
• Not Classified Reason: For Export Only
• Submission Type: Contact ODE
• Device Class: Not Classified
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible