Product Classification

• Device: orthosis, spondylolisthesis spinal fixation
• Regulation Description: Pedicle screw spinal system.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: MNH
• Submission Type: 510(k)
• Regulation Number: 888.3070
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ASTM F1798-97(Reapproved 2008) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
• 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 F1717-12 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• ASTM F 2026-10 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• ASTM F2024-10 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
• ASTM F2193-02(2007) Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

Guidance Document

• Spinal System 510(k)s - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible