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U.S. Department of Health and Human Services

Product Classification

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Device orthosis, spinal pedicle fixation
Regulation Description Pedicle screw spinal system.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeMNI
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Posterior Spine Devices Branch (PSDB)
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
Guidance Document
  • Spinal System 510(k)s - Guidance for Industry and FDA Staff
Third Party Review Not Third Party Eligible
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