Shoulder Options, Inc.
United StatesFDA applicant, unverified
Shoulder Options, Inc. is a medical device manufacturer, with 105 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 12 Nov 2026.
- Devices
- 105
Registry facts
- Registries
- FDA GUDID 102
- FDA 510(k) 3
- Device classes
- FDA Class II 105
- Identifiers
- DUNS 053545528
What Shoulder Options, Inc. makes
Shoulder Options, Inc. manufactures orthopaedic hardware for shoulder and proximal humerus fracture fixation, including non-bioabsorbable bone screws, fixation plates, and reusable surgical instruments like drills, guides, and screwdrivers. Their portfolio includes systems such as the GTFx™ Greater Tuberosity Fracture Plate System and the CRP™ Cuff Repair Plate System, designed for internal fixation of complex shoulder fractures. The company also produces reusable aiming blocks and surgical connectors to assist in precise implant placement during orthopaedic procedures.
All devices are classified as Class II under US regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The company operates from the United States, adhering to regulatory requirements for medical devices in that jurisdiction.
Catalogue
Search and filter all 105 devicesShowing 1-50 of 105
Company details
- DUNS number
- 053545528
- Phone
- 704-512-0000
Frequently asked questions
How many devices does Shoulder Options, Inc. have in the registry?
The registry currently lists 105 devices for Shoulder Options, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shoulder Options, Inc.'s devices?
Among its 50 most recently registered devices, Shoulder Options, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Shoulder Options, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Shoulder Options, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shoulder Options, Inc. in the registry?
The most recently registered devices listed for Shoulder Options, Inc. include GTFx™ Greater Tuberosity Fracture Plate System SO03-3151, AFT™ Proximal Humerus Fracture Plate System SO02-3006-50, AFT™ Proximal Humerus Fracture Plate System SO02-3087 and AFT™ Proximal Humerus Fracture Plate System SO02-3005-37.5.