Product Classification

• Device: prosthesis, elbow, hemi-, radial, polymer
• Regulation Description: Elbow joint radial (hemi-elbow) polymer prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: KWI
• Submission Type: 510(k)
• Regulation Number: 888.3170
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ASTM F 983-86 (Reapproved 2009) Standard Practice for Permanent Marking of Orthopaedic Implant Components
• ASTM F 565-04 (Reapproved 2009)e1 Standard Practice for Care and Handling of Orthopedic Implants and Instruments

Third Party Review

Not Third Party Eligible