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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeOQB
Regulation Number 888.3085
Device Class 2


Premarket Reviews
ManufacturerDecision
SPINEOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3

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