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Reimbursement / Regulatory

Paradigm Spine Gains PMA for coflex Disposable Instrument Kit -

Paradigm Spine was granted supplemental FDA pre-market approval (PMA) for the coflex® Interlaminar Stabilization® disposable instrument kit. This marks the first approved disposable spinal instrument set for a Class III spinal device to receive a supplemental PMA. The kit will include a complete set of injection molded instruments delivered in a pre-sterilized peel pack, especially ideal for outpatient/ambulatory care settings. (Paradigm Spine LLC, 5/2/18)