Smith and Nephew Donjoy, Inc.
United StatesFDA applicant, unverified
- Devices
- 15
What Smith and Nephew Donjoy, Inc. makes
Smith and Nephew Donjoy, Inc. manufactures orthopedic and rehabilitation devices, including cannulated ACL screws for knee ligament repair, electromyography systems for muscle assessment, electrical muscle stimulators, cold therapy devices, and wheelchair accessories. Their portfolio also covers surgical instrumentation for ACL procedures and restraint systems for patient safety.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded in the FDA’s 510(k) clearance registry. Products are listed under U.S. jurisdiction, adhering to FDA requirements for medical device authorisation.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Smith and Nephew Donjoy, Inc. have in the registry?
The registry currently lists 15 devices for Smith and Nephew Donjoy, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smith and Nephew Donjoy, Inc.'s devices?
Among its 15 most recently registered devices, Smith and Nephew Donjoy, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Smith and Nephew Donjoy, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Smith and Nephew Donjoy, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Smith and Nephew Donjoy, Inc. in the registry?
The most recently registered devices listed for Smith and Nephew Donjoy, Inc. include AIMS CANNULATED ACL SCREW (7MM DIAMETER), MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR, BRACE NEUTRALIZER and PROTECTIVE RESTRAINT.