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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, spinous process spacer/plate
Definition This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process.
Review Panel Orthopedic
Product CodeNQO
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Posterior Spine Devices Branch (PSDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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