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Omega Surgical Instruments, Inc.

Country not established FDA establishment FEI 1000220740

Devices
847
Registrations
FDA
FDA recalls
0

What Omega Surgical Instruments, Inc. makes

Omega Surgical Instruments, Inc. manufactures orthopedic fixation devices, including K-wires and Steinmann pins for bone stabilization, as well as surgical tools such as general and plastic surgery bur instruments and saw blades for bone or tissue cutting.

The company’s portfolio includes Class I and Class II devices, with products listed under the FDA’s 510(k) clearance process. The manufacturer is based in the United States.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue847

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Company details

FDA FEI number
1000220740
Address
1072 S. Elms Road, Flint, MI, 48532

Frequently asked questions

How many devices does OMEGA SURGICAL INSTRUMENTS, INC. have in the registry?

The registry currently lists 847 devices for OMEGA SURGICAL INSTRUMENTS, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list OMEGA SURGICAL INSTRUMENTS, INC.'s devices?

Among its 50 most recently registered devices, OMEGA SURGICAL INSTRUMENTS, INC. has devices listed in FDA GUDID (50 devices).

What risk classes do OMEGA SURGICAL INSTRUMENTS, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for OMEGA SURGICAL INSTRUMENTS, INC.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from OMEGA SURGICAL INSTRUMENTS, INC. in the registry?

The most recently registered devices listed for OMEGA SURGICAL INSTRUMENTS, INC. include N/A S702L-60-01NS, N/A MR10BA50, N/A MR10MH30 and N/A MR14BA40D.

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.