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U.S. Department of Health and Human Services

Product Classification

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Device reherniation reduction device
Definition The device is intended to reduce the incidence of reherniation, and reoperation following primary limited lumbar discectomy procedures (excision of herniated intervertebral disc).
Physical State The device is made of a metal component with a polymer mesh flap intended to cover the annular defect.
Technical Method The device is intended to block the annular defect to prevent reherniation of nucleus material. The device also creates lesion in the vertebral body that may also prevent the herniation of the nucleus material out of the annulus.
Target Area The device is implanted into the vertebral body and rests in the intervertebral space within the annulus.
Review Panel Orthopedic
Product CodeQES
Premarket Review Spinal Devices (DHT6B)
Spinal Devices (DHT6B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible