Sofamor Danek USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 42
What Sofamor Danek USA, Inc. makes
The company manufactures spinal fixation systems, including posterior and anterior cervical and thoracic plates, screws, and plating systems for surgical stabilization. It also produces titanium-based spinal implants and endoscopic tools, such as the INCL endoscope, for minimally invasive procedures. These devices are designed for orthopedic applications in spinal surgery, including fusion and correction of deformities.
The portfolio includes Class II and Unclassified (U) devices, all of which are listed via the FDA’s 510(k) pathway. These products are regulated under U.S. medical device laws and are intended for commercial distribution within the United States.
Catalogue
Search and filter all 42 devicesFrequently asked questions
How many devices does Sofamor Danek USA, Inc. have in the registry?
The registry currently lists 42 devices for Sofamor Danek USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sofamor Danek USA, Inc.'s devices?
Among its 42 most recently registered devices, Sofamor Danek USA, Inc. has devices listed in FDA 510(k) (42 devices).
What risk classes do Sofamor Danek USA, Inc.'s devices fall under?
Among its 42 most recently registered devices, the classes recorded for Sofamor Danek USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sofamor Danek USA, Inc. in the registry?
The most recently registered devices listed for Sofamor Danek USA, Inc. include TSRH SPINAL SYSTEM, PARAGON POSTERIOR SPINAL SYSTEM, ORION ANTERIOR CERVICAL PLATE SYSTEM and TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS).