Medical Device Manufacturer · IL , Caesarea

OSSIO , Ltd. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2019

Total

Cleared

Denied

OSSIO, Ltd. specializes in orthopedic fixation and soft tissue repair devices. The company operates with a manufacturing facility in Caesarea, IL.

OSSIO has received 20 FDA 510(k) clearances from 20 total submissions since 2019. The company's portfolio focuses entirely on orthopedic solutions, including fixation nails, suture anchors, interference screws, and compression staples. The latest clearance in 2026 reflects continued regulatory activity and product development.

OSSIO's OSSIOfiber® product family represents the company's core technology platform for orthopedic fixation and soft tissue repair. Recent cleared devices include threaded trimmable fixation nails, suture anchors, interference screws, and compression staples-all designed for orthopedic surgical applications.

Explore the complete list of device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Mcra, LLC as regulatory consultant.

FDA 510(k) Regulatory Record - OSSIO , Ltd.

20 devices

1-12 of 20