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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, posterior spinal elements
Definition This device is a non-fusion, load-bearing implanted prosthesis that stabilizes the spine following resection of posterior spinal elements.
Physical State This device is a posterior prosthesis fixed to the spine by four pedicle screws.
Technical Method This device is designed to provide posterior, non-fusion stabilization following decompression.
Target Area This device is intended to be implanted in the posterior lumbar spine.
Review Panel Orthopedic
Product CodeQWK
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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