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U.S. Department of Health and Human Services

Product Classification

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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 CodeMAX
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
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
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
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