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Regulatory

FDA 510(k) Recap: Spinal Devices and Technologies from 1H19

With the NASS 2019 Annual Meeting approaching, it's an ideal time to revisit spine products that have gained FDA 510(k) clearance in the first half of the year. This round-up shares another entrant into the sacroiliac joint treatment arena, an implant company’s first clearance for an enabling technology and additional details about some lesser-known companies to watch.

How the EU’s MDR Will Impact Your Supply Chain

The forthcoming EU Medical Device Regulation will impact your supply chain, both in manufacturing and distribution. You must talk with your partners now to ensure that you possess the information you need from them—and they from you—to meet regulatory requirements, your timeline for CE Market Approval and critical considerations for audits. Mike Wolf, Director of Solutions Delivery at Maetrics, outlines some talking points for you and your suppliers.

FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances

To meet your need to know who’s new in the orthopaedic market, I sorted through the 21 companies receiving their first orthopaedic-related FDA 510(k) clearance through May of this year. To keep things simple, I then chose one company from each implantable market segment for a closer look. Here’s what I found.

510(k) Q&A: How Many Ex-U.S.-Headquartered Companies Recently Received FDA Clearance?

Recent conversations surrounding international interest in the U.S. market led us to consider how many ex-U.S.-headquartered companies have achieved an orthopaedic-related 510(k) clearance in recent years.

Postmarket Surveillance and M&A

Data collection is paramount to the success of any orthopaedic device. What happens to the much-coveted postmarket data/initiative during and after a merger or acquisition? We posed this question to Vicki Anastasi, Vice President & Global Head, Medical Devices & Diagnostics Research with ICON plc.

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