Product Classification

• Device: holder, head, neurosurgical (skull clamp)
• Regulation Description: Neurosurgical head holder (skull clamp).
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: HBL
• Premarket Review: Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A); Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
• Submission Type: 510(k)
• Regulation Number: 882.4460
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 17-17 ASTM F3395/F3395M-19
  Standard Specification for Neurosurgical Head Holder Devices

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc