Bonutti Research, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 17
What Bonutti Research, Inc. makes
Bonutti Research, Inc. manufactures orthopedic fixation and soft tissue repair devices, including ultrasonic therapy systems, resorbable and absorbable suture anchors, fracture fixation systems, and specialized anchors for bone and soft tissue applications. Their portfolio includes systems like the TRANSET for fracture stabilization, the UNITY series for soft tissue fixation with PLLA anchors, and the JAS Pulse ultrasonic therapy device. Additional products include conical tip suture anchors, multitak suture snap systems, and a 3.0 mm resorbable anchor for splinter fixation.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Their products are listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device authorization requirements. The manufacturer operates from the United States.
Catalogue
Search and filter all 17 devicesFrequently asked questions
How many devices does Bonutti Research, Inc. have in the registry?
The registry currently lists 17 devices for Bonutti Research, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bonutti Research, Inc.'s devices?
Among its 17 most recently registered devices, Bonutti Research, Inc. has devices listed in FDA 510(k) (17 devices).
What risk classes do Bonutti Research, Inc.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for Bonutti Research, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bonutti Research, Inc. in the registry?
The most recently registered devices listed for Bonutti Research, Inc. include MULTITAK SS SUTURE SYSTEM, TRANSET SYSTEM, UNITY ALPHA SYSTEM and UNITY BETA ANCHOR SYSTEM.