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Reimbursement / Regulatory

Amedica Provides Regulatory Updates: Taurus and Valeo -

Amedica's (AMDA) Taurus pedicle screw system, announced in its 3Q16 revenue highlights, has received FDA 510(k) clearance for marketing. First implantation and full market launch are slated to occur by year-end. 

Further, AMDA was notified that FDA did not clear its 510(k) premarket application to commercialize Valeo C+CsC, a composite spinal fusion device for which a submission was filed in 1Q15. AMDA is working with FDA to examine other ways to introduce this technology to the U.S. market.

Sources: Amedica Corporation; FDA.gov; ORTHOWORLD Inc.

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