Custom Orthopaedic Solutions, Inc.
United StatesFDA applicant, unverified
- Devices
- 34
What Custom Orthopaedic Solutions, Inc. makes
The company manufactures reusable orthopaedic surgical instruments, including the Glenoid Intelligent Reusable Instrument System (Glenoid IRIS) and its associated SmartBase attachment for shoulder procedures. It also provides preoperative planning software, such as the Arthrex OrthoVis Preoperative Plan, and a web-based portal (ArthrexVIP/Web Portal) for surgical planning and case management in orthopaedic surgery.
These products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) clearance process. The company is based in the United States and its devices are listed in the FDA’s 510(k) registry.
Catalogue
Search and filter all 34 devicesCompany details
- DUNS number
- 078667390
- [email protected]
- Phone
- 2168005905
Frequently asked questions
How many devices does CUSTOM ORTHOPAEDIC SOLUTIONS, INC. have in the registry?
The registry currently lists 34 devices for CUSTOM ORTHOPAEDIC SOLUTIONS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list CUSTOM ORTHOPAEDIC SOLUTIONS, INC.'s devices?
Among its 34 most recently registered devices, CUSTOM ORTHOPAEDIC SOLUTIONS, INC. has devices listed in FDA 510(k) (8 devices) and FDA GUDID (26 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do CUSTOM ORTHOPAEDIC SOLUTIONS, INC.'s devices fall under?
Among its 34 most recently registered devices, the classes recorded for CUSTOM ORTHOPAEDIC SOLUTIONS, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from CUSTOM ORTHOPAEDIC SOLUTIONS, INC. in the registry?
The most recently registered devices listed for CUSTOM ORTHOPAEDIC SOLUTIONS, INC. include Glenoid IRI Leg (13mm), Glenoid IRI Leg (14mm), SmartBase Ruler K and Glenoid IRI Leg (23mm).