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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, spinous process tension band implant
Definition This device is a non-fusion, tension band implant that is intended to provide dynamic flexion-restricting stabilization of the spine following a lumbar decompression.
Physical State This device includes a tension band and implant that span adjacent spinous processes.
Technical Method This device is intended to provide dynamic flexion-restricting stabilization of the spine following a lumbar decompression.
Target Area Posterior lumbar spine (L3-L5).
Review Panel Orthopedic
Product CodeSGK
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
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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