FDA 510(k) Recap: Spine Company Clearances

Spine continues to commercialize more products than other orthopedic sectors due to players of all sizes launching a robust list of new products each year. This month, we recap multiple launches from CarboFix Orthopedics, Cutting Edge Spine, Life Spine, Medacta and SeaSpine.

10 Spine Companies Receive Their First FDA 510(k)

Thus far in 2020, ten companies received their FDA 510(k) clearances that were not only firsts for the company, but also obtained for a spine product.

FDA 510(k) Recap: First Clearances in 2020

We profile five companies that received their first FDA 510(k) clearances in 2020. Three of these companies are headquartered outside of the U.S. and these clearances mark their entry into the market.

FDA 510(k) Recap: Companies Gain Trauma Device Clearances

As the Orthopedic Trauma Association holds its Annual Meeting this week, we look at companies that seek to make a clinical difference in trauma surgery.

Arthroscopy/Soft Tissue Technologies to Watch: 1H17 Funding Recap

Funding announcements that we tracked from orthopaedic companies in 1H17 included eight arthroscopy/soft tissue-related technologies we’d like to highlight because of their novelty and early-stage backing.

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.