Product Classification

• Device: stimulator, spinal-cord, implanted (pain relief)
• Regulation Description: Implanted spinal cord stimulator for pain relief.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: GZB
• Premarket Review: Neuromodulation and Physical Medicine Devices (DHT5B); Neuromodulation and Physical Medicine Devices (DHT5B)
• Submission Type: 510(k)
• Regulation Number: 882.5880
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 8-558 ASTM F3333-20
  Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• 17-15 ISO 14708-3 Second edition 2017-04
  Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators

Third Party Review

Not Third Party Eligible