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U.S. Department of Health and Human Services

Product Classification

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Device spinous process plate
Definition A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor. It is not intended for stand-alone use.
Physical State Plates with teeth/spikes and crossbar/tray/bumper that connects and locks plates together, metallic, metallic and polymer combination
Technical Method Placed between two spinous processes to immobilize the segment, provide supplemental stabilization, and to facilitate fusion at the treated level
Target Area Non-cervical spine (T1-S1)
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodePEK
Premarket Review Spinal Devices (DHT6B)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.3050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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