Product Classification

• Device: accessories, fixation, spinal interlaminal
• Regulation Description: Spinal interlaminal fixation orthosis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: LYP
• Premarket Review: Office of Orthopedic Devices (OHT6); Spinal Devices (DHT6B)
• Submission Type: 510(k)
• Regulation Number: 888.3050
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 4-320 ISO 13402 First edition 1995-08-01
  Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
• 8-344 ISO 7153-1 Second edition 1991-04-01
  Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)]
• 8-478 ASTM F1089-18
  Standard Test Method for Corrosion of Surgical Instruments
• 11-197 ASTM F983-86 (Reapproved 2018)
  Standard Practice for Permanent Marking of Orthopaedic Implant Components
• 11-199 ASTM F565-04 (Reapproved 2018)
  Standard Practice for Care and Handling of Orthopedic Implants and Instruments

Third Party Review

Not Third Party Eligible