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Reimbursement / Regulatory

Strategic Orthopaedic-related 510(k)s issued in July 2016 -

Each month, ORTHOWORLD examines updates to FDA's orthopaedic-related 510(k) database and highlights those products deemed strategic, defined as a company's first 510(k) clearance, first clearance in a segment that is new to the company, clearance for a type of device not formerly marketed by a company, etc.

In the following list, companies receiving a first orthopaedic-related 510(k) are denoted with an asterisk.

Integra External Fixation System (Ascension Orthopedics/Integra); CorticaLink Spinal Fusion Platform (FacetLink dba LinkSpine); Lumbar Interbody Fusion Device (Keos*); MectALIF Anterior Standalone Intervertebral Fusion Device (Medacta); Cure Anterior Cervical Plate (Meditech Spine); Cannulated Screw (Miami Device Solutions); Belvedere Lateral Plating System (NeuroStructures); NEO Arthroscope (Prosurg)

View the full list of orthopaedic 510(k)s for July 2016 here.

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