Product Classification

• Device: intervertebral fusion device with bone graft, lumbar
• Regulation Description: Intervertebral body fusion device.
• Definition: Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
• Physical State: hollow cylinder or rectangular box made of metal or polymer
• Technical Method: Acts as a disc spacer and holds bone graft.
• Target Area: intervertebral disc space
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: MAX
• Submission Type: 510(k)
• Regulation Number: 888.3080
• 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 F2077-11 Test Methods for Intervertebral Body Fusion Devices
• ASTM F2267-04 (Reapproved 2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

Guidance Document

• Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device

Third Party Review

Not Third Party Eligible