Product Classification

• Device: tester, stiffness, cartilage, arthroscopic
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: NGR
• Premarket Review: Stereotaxic, Trauma and Restorative Devices (DHT6C); Stereotaxic, Trauma and Restorative Devices (DHT6C)
• Submission Type: 510(k)
• Regulation Number: 888.1100
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

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