Expanded FDA 510(k) for First Ray Stealth Staple

First Ray received FDA 510(k) clearance for additional sizes and materials in the Stealth Staple™ line.

The original 2Q16 clearance addressed standard-sized implants in titanium alloy, and the new clearance includes standard sizes in PEEK, small sizes in titanium alloy or PEEK and mini options in titanium alloy.

Stealth Staples are completely contained within bone, offering the potential to substantially reduce clinical complications related to prominent hardware associated with current standard-of-care devices.

First Ray is a development stage medical device company incubated and operated by Surgical Frontiers. Inquiries regarding distribution and commercialization partnerships are welcome.

Sources: First Ray/Surgical Frontiers LLC; ORTHOWORLD Inc.