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Turnkey Intergration USA, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
26

What Turnkey Intergration USA, Inc. makes

Turnkey Integration USA, Inc. manufactures orthopedic fixation and revision systems, including humerus plates, intramedullary nail systems for humeral fractures, and modular hip prostheses. Their portfolio includes cemented and uncemented hip stems, acetabular revision cups, and components for spinal and long-bone stabilization. Additional products cover cement restrictors, saddle prostheses, and specialized valves for orthopedic applications.

The company’s devices are classified under FDA regulations as Class II and Class III, with submissions recorded via the 510(k) pathway. Products are listed in the U.S. under the FDA’s regulatory framework. The manufacturer operates from the United States.

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

Catalogue26

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  • May Humerus Plates Ref K912936

    Class II
    Active 510(k) 510(k) II

  • Omni-Fix, Nail System Ref K990307

    Class II
    Active 510(k) 510(k) II

  • Link Saddle Prothesis Ref K951355

    Class II
    Active 510(k) 510(k) II

  • Link Cement Plug Ref K972411

    Class II
    Active 510(k) 510(k) II

  • System 22 Valve Ref K950397

    Class II
    Active 510(k) 510(k) II

  • Lubinus Sp Ii Hip System Ref K953653 Open recall

    Class II
    Active 510(k) 510(k) II

  • B2C, Espace Revision Cup System Ref K990523

    Class II
    Active 510(k) 510(k) II

  • Q System 28 Hip Stem Ref K910010

    Class II
    Active 510(k) 510(k) II

  • Lima Cement Restrictor Ref K911338

    Class II
    Active 510(k) 510(k) II

  • Omni-Fix, Humeral Nail Ref K991405

    Class II
    Active 510(k) 510(k) II

  • Intrinsic Stem Ref K923911

    Class II
    Active 510(k) 510(k) II

  • Modified Freeman Revision Acetabular Cup Ref K902111

    Class III
    Active 510(k) 510(k) III

  • C-Fit Cemented Hip Stem Ref K923898

    Class II
    Active 510(k) 510(k) II

  • Artos, Diplos System Ref K970284

    Class II
    Active 510(k) 510(k) II

  • Venus Hip Ref K913708

    Class II
    Active 510(k) 510(k) II

  • Lima Rps Shoulder Ref K913282

    Class II
    Active 510(k) 510(k) II

  • Nuffield Total Knee Ref K931960

    Class II
    Active 510(k) 510(k) II

  • Feldmuehle Ceramic Head (12/14 X 32mm) Ref K910548

    Class II
    Active 510(k) 510(k) II

  • Universal Wrist Ref K940297

    Class II
    Active 510(k) 510(k) II

  • Feldmuehle Ceramic Head (12/14 X 28mm) Ref K910547

    Class II
    Active 510(k) 510(k) II

  • Link Endo Model Revision Cup Ref K943986

    Class II
    Active 510(k) 510(k) II

  • Lima 28mm Ceramic Head, Modification Ref K912985

    Class II
    Active 510(k) 510(k) II

  • Link Saddle Prothesis Ref K943277

    Not classified
    Active 510(k) 510(k) —

  • Modified Freeman Acetabular Cup Ref K902110

    Class III
    Active 510(k) 510(k) III

  • Link Cerclage Wire System Ref K970084

    Class II
    Active 510(k) 510(k) II

  • Vsp Hip Stem Ref K903957

    Class II
    Active 510(k) 510(k) II

Rows 1-26 of 26

Frequently asked questions

How many devices does Turnkey Intergration USA, Inc. have in the registry?

The registry currently lists 26 devices for Turnkey Intergration USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Turnkey Intergration USA, Inc.'s devices?

Among its 26 most recently registered devices, Turnkey Intergration USA, Inc. has devices listed in FDA 510(k) (26 devices).

What risk classes do Turnkey Intergration USA, Inc.'s devices fall under?

Among its 26 most recently registered devices, the classes recorded for Turnkey Intergration USA, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from Turnkey Intergration USA, Inc. in the registry?

The most recently registered devices listed for Turnkey Intergration USA, Inc. include MAY HUMERUS PLATES, OMNI-FIX, NAIL SYSTEM, LINK SADDLE PROTHESIS and LINK CEMENT PLUG.

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