Product Classification

• Device: system, cement removal extraction
• Regulation Description: Sonic surgical instrument and accessories/attachments.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: LZV
• Premarket Review: Restorative, Repair and Trauma Devices (DHT6C); Restorative, Repair and Trauma Devices (DHT6C)
• Submission Type: 510(K) Exempt
• Regulation Number: 888.4580
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible

Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 11-199 ASTM F565-04 (Reapproved 2018)
  Standard Practice for Care and Handling of Orthopedic Implants and Instruments

Third Party Review

Not Third Party Eligible