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Hayes Medical, Inc.

United StatesFDA applicant, unverified

Devices
12

What Hayes Medical, Inc. makes

Hayes Medical, Inc. manufactures orthopedic implants for hip and knee replacements, including bone screws, modular hip systems, patient-specific femoral components, acetabular shells, polyethylene inserts, cobalt-chrome (CoCr) femoral heads, and modular hip and knee systems. Products include titanium-coated acetabular shells, porous femoral components, and cross-linked polyethylene inserts designed for hip arthroplasty. The portfolio also covers modular hip systems with plasma-sprayed coatings and unipolar heads for hip replacements.

The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) registry. The manufacturer operates from the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Hayes Medical, Inc. have in the registry?

The registry currently lists 12 devices for Hayes Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hayes Medical, Inc.'s devices?

Among its 12 most recently registered devices, Hayes Medical, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Hayes Medical, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Hayes Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Hayes Medical, Inc. in the registry?

The most recently registered devices listed for Hayes Medical, Inc. include CORTICELLOUS BONE SCREW, UNISYN HA PLASMA MODULAR HIP, PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT and CONSENSUS ACETABLAR SHELL, TI COATED.

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