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Legal, Clinical & Regulatory

The Fused and the Fractured: Spine, Trauma Companies Receive 510(k) Clearance in July

Globus Medical has received clearance for its first two trauma products. While they prepare to enter that space, numerous competitors are bringing out interbody fusion devices for introduction in U.S.   

Trauma and Spine Gain New Players with First 510(k)s in 1H17

In 1H17, 23 orthopaedic companies from 11 countries received their first 510(k), according to our scan of FDA’s database. Nine of the 23 510(k)s were in trauma and seven in spine.

Hip and Spine: New Players Receive FDA 510(k)s

Of the 56 orthopaedic-related 510(k)s that FDA released in June, we share observations and insights on two total hips, one interbody fusion system and a pedicle screw system.