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Medical Devices / Submissions and Approvals

Medicrea Receives Final 510(k) Clearance for Surgical Planning Software

Aug. 19, 2019

The FDA has handed Medicrea 510(k) clearance for its Tulip Genesis, a top loading screw system used with the company’s thoraco-lumbar fixation system.

The company said the agency’s decision is the final clearance for its UNid ASI (adaptive spine intelligence) surgical planning platform.

The software system provides implant logistics in the operating room that are useful to hospital and surgical staff, and allows surgeons to put together a surgical plan for patient-specific implants.

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