Product Classification

• Device: appliance, fixation, spinal interlaminal
• Regulation Description: Spinal interlaminal fixation orthosis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: KWP
• 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

• 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
• 11-276 ASTM F1798-13
  Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
• 11-346 ASTM F2706-18
  Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
• 11-369 ASTM F3292-19
  Standard Practice for Inspection of Spinal Implants Undergoing Testing
• 11-375 ASTM F2193-20
  Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• 11-388 ASTM F1717-21
  Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• 11-402 ASTM F1798-21
  Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

Third Party Review

Not Third Party Eligible