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Optimotion Implants, LLC

United Statesfrom the FDA registration address FDA establishment FEI 3016470314

Optimotion Implants, LLC is a medical device manufacturer, with 499 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 12 Nov 2026.

Devices
499
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 496
  • FDA 510(k) 3

A device listed in two registries counts in both.

Device classes
  • FDA Class II 499
Identifiers
  • FDA FEI 3016470314

What Optimotion Implants, LLC makes

Optimotion Implants, LLC manufactures cruciate-retaining total knee prostheses, including the Optimotion Blue CR HCCR Total Knee System. The company also produces reusable joint prosthesis implantation kits designed for surgical use in knee replacements.

The company’s products are classified as Class II medical devices under U.S. regulations and are listed in the FDA’s Unique Device Identifier (UDI) database.

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

Catalogue499

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Company details

FDA FEI number
3016470314
Address
6052 Turkey Lake Road, Orlando, FL, 32819

Frequently asked questions

How many devices does OPTIMOTION IMPLANTS, LLC have in the registry?

The registry currently lists 499 devices for OPTIMOTION IMPLANTS, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list OPTIMOTION IMPLANTS, LLC's devices?

Among its 50 most recently registered devices, OPTIMOTION IMPLANTS, LLC has devices listed in FDA GUDID (50 devices).

What risk classes do OPTIMOTION IMPLANTS, LLC's devices fall under?

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

What are the newest devices from OPTIMOTION IMPLANTS, LLC in the registry?

The most recently registered devices listed for OPTIMOTION IMPLANTS, LLC include Optimotion Blue CR HCCR Total Knee System 1014-F-3200, Optimotion Blue CR HCCR Total Knee System 1014-F-3300, Optimotion Blue CR HCCR Total Knee System 1014-F-3400 and Optimotion Blue CR HCCR Total Knee System 1014-F-3500.

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.