Product Classification

• Device: accessories, fixation, spinal interlaminal
• Regulation Description: Spinal interlaminal fixation orthosis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: LYP
• Submission Type: 510(k)
• Regulation Number: 888.3050
• 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 F1089-10 Standard Test Method for Corrosion of Surgical Instruments
• ISO 7153-1:1991/Amd. 1:1999 Surgical instruments -- Metallic materials -- Part 1: Stainless steel
• ISO 13402:1995 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure

Third Party Review

Not Third Party Eligible