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U.S. Department of Health and Human Services

Product Classification
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Device intervertebral body graft containment device
Regulation Description Intervertebral body graft containment device.
Definition An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.
Physical State Non-rigid device intended to be used with bone graft and supplemental fixation.
Technical Method Placed between two vertebral bodies and holds bone graft.
Target Area Lumbar intervertebral disc space.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOQB
Premarket Review Office of Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.3085
Device Class 2
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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