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Reimbursement / Regulatory

Medicrea Gains FDA Clearance for Patient-Specific Spinal Cage -

Medicrea obtained the first FDA 510(k) clearance to market patient-specific spinal cages. Using the UNiD™ artificial intelligence-driven ASI™ (Adaptive Spine Intelligence) platform, the company can now support digital planning, in-house manufacture and supply of devices from its IB3D™ line of 3D-printed titanium interbody devices. UNiD IB3D is designed as an alternative to the surgeon testing among available sizes to select an implant that will suit the patient (but which lacks optimization). (Medicrea, 5/31/18)