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Reimbursement / Regulatory

Intelligent Implant Systems Receives 510(k) Clearance for 2-Level Revolution System -

Intelligent Implant Systems received FDA 510(k) clearance to market 2-level components for the Revolution™ Spinal System, allowing for use in 2-level posterior thoracolumbar fusion.

The all-sterile implants are accompanied by a single tray of all-sterile instruments, eliminating the need for the hospital or ASC to sterilize anything for the procedure. The 2-level system utilizes existing Revolution™ Connectors, and requires only a minimum of additional components vs. the 1-level system.

Source: Intelligent Implant Systems, LLC

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