Product Classification

• Device: neurological stereotaxic instrument
• Regulation Description: Stereotaxic instrument.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: HAW
• Submission Type: 510(k)
• Regulation Number: 882.4560
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.