Product Classification

• Device: fastener, fixation, nondegradable, soft tissue
• Regulation Description: Smooth or threaded metallic bone fixation fastener.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: MBI
• Submission Type: 510(k)
• Regulation Number: 888.3040
• 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
• ASTM F543-07 Standard Specification and Test Methods for Metallic Medical Bone Screws
• ASTM F1839-08e2 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

Third Party Review

Not Third Party Eligible