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
• Submission Type: 510(k)
• Regulation Number: 888.4580
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• ASTM F 565-04 (Reapproved 2009)e1 Standard Practice for Care and Handling of Orthopedic Implants and Instruments

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

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