Product Classification

• Device: prosthesis, elbow, hemi-, humeral, metal
• Regulation Description: Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
• Definition: Call for pmas to be filed by 12/26/96 per 61 fr 50709 on 9/27/96.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: KWJ
• Submission Type: PMA
• Regulation Number: 888.3180
• Device Class: 3
• 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