Amedica Provides Regulatory Updates: Taurus and Valeo

By Julie A. Vetalice

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.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory