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Encore Orthopedics, Inc.

United StatesFDA applicant, unverified

Devices
85

What Encore Orthopedics, Inc. makes

Encore Orthopedics, Inc. manufactures orthopedic fixation devices, including external fixators for bone stabilization, porous-coated hemispherical and flared shells for joint augmentation, and porous hip stems for femoral implants. The company also produces spinal systems like the PASS and ISOBAR modifications, knee augmentation blocks, and calcium sulfate bone void fillers for defect filling. Additional offerings include press-fit shells and screws for orthopedic stabilization.

The portfolio includes devices classified as Class II and Class III under FDA regulations, with most products cleared via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry. The company is headquartered in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Encore Orthopedics, Inc. have in the registry?

The registry currently lists 85 devices for Encore Orthopedics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Encore Orthopedics, Inc.'s devices?

Among its 50 most recently registered devices, Encore Orthopedics, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Encore Orthopedics, Inc.'s devices fall under?

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

What are the newest devices from Encore Orthopedics, Inc. in the registry?

The most recently registered devices listed for Encore Orthopedics, Inc. include 6.5 MM CANCELLOUS BONE SCREW, BERLIN EXTERNAL FIXATOR, MODIFICATION TO ISOBAR SPINAL SYSTEM and FOUNDATION KNEE AUGMENTATION BLOCKS.

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