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SHOULDER INNOVATIONS, Inc

Also registered as Shoulder Innovations, LLC

United Statesfrom the FDA registration address FDA establishment FEI 3012544635

SHOULDER INNOVATIONS, Inc is a medical device manufacturer, with 719 devices listed in FDA GUDID and FDA 510(k) (FDA Class II, I and III) as of 12 Nov 2026.

Devices
719
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 707
  • FDA 510(k) 12

A device listed in two registries counts in both.

Device classes
  • FDA Class II 714
  • FDA Class I 4
  • FDA Class III 1
Identifiers
  • FDA FEI 3012544635

What SHOULDER INNOVATIONS, Inc makes

Shoulder Innovations, Inc manufactures reusable orthopaedic prosthesis implantation positioning instruments, total shoulder prostheses, total reverse shoulder prostheses, prefabricated shoulder glenoid fossa prostheses, coated shoulder humeral stem prostheses, stem-fixed metallic humeral head prostheses, press-fit shoulder humeral stem prostheses, and reusable device sterilization/disinfection containers.

The company's devices are classified as Class I and Class II medical devices and are listed in the FDA UDI registry.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue719

Newest first, rows 1-50 of 719

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Rows 1-50 of 719

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Company details

FDA FEI number
3012544635
Address
1535 Steele Ave SW, Grand Rapids, MI, 49507

Frequently asked questions

How many devices does SHOULDER INNOVATIONS, Inc have in the registry?

The registry currently lists 719 devices for SHOULDER INNOVATIONS, Inc. Devices recorded under merged duplicate company entries are counted once.

Which registries list SHOULDER INNOVATIONS, Inc's devices?

Among its 50 most recently registered devices, SHOULDER INNOVATIONS, Inc has devices listed in FDA GUDID (50 devices).

What risk classes do SHOULDER INNOVATIONS, Inc's devices fall under?

Among its 50 most recently registered devices, the classes recorded for SHOULDER INNOVATIONS, Inc's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from SHOULDER INNOVATIONS, Inc in the registry?

The most recently registered devices listed for SHOULDER INNOVATIONS, Inc include Shoulder Innovations Humeral Short Stem System Humeral Head Trial Insert, Shoulder Innovations Total Shoulder System 14mm x 38mm, Shoulder Innovations Total Shoulder System 15mm x 40mm and Shoulder Innovations Total Shoulder System 15mm x 44mm.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company and no recalls are recorded.