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Sintea Plustek, LLC

Also registered as SINTEA PLUSTEK SRL, Sintea Plustek

United StatesFDA applicant, unverified

Devices
874

What Sintea Plustek, LLC makes

Sintea Plustek, LLC manufactures spinal fixation hardware, including trans-facet screws and non-bioabsorbable spinal plates for internal fixation, as well as metallic spinal fusion cages for interbody use. Their portfolio also includes endoscopic-access dilators for minimally invasive procedures and orthopaedic bone wires for skeletal stabilization. The company produces both sterile and non-sterile devices for spinal and orthopaedic applications.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue874

Newest first, rows 1-50 of 874

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  • Pls-10090T57

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-48T5120

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-440T57

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-550T56

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-530T540

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-5085T58

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-47CC1

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-960T55

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Acp-01T520

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Plif Lite Lfc-001PK2614

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-10050T57

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Dsc-34PK0

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-67T57

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-845T58

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-10035T55

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-10050T56

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-875T56

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-10095T56

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-635T540

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-450T55

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Acp-02T519

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-10030T540

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-655T57

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-150T324

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-755T55

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-5075T540

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-45T51

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-10080T58

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-535T54

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Dsc-22T50

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-755T56

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-630T56

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Plif Lite Lfc-001PK2608

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-69T57

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-1090T57

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-10030T55

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-5080T57

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-840T58

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Acp-10T514

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-560T56

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-48T5070

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-935T57

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-175T57

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-4100T58

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-5075T55

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-640T540

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-133T50

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-49T5070

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-170T59

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Pls-46T52

    Active Regimes: 510(k) Registry: GUDID Class:II

Rows 1-50 of 874

Showing 1-50 of 874

Frequently asked questions

How many devices does Sintea Plustek, LLC have in the registry?

The registry currently lists 874 devices for Sintea Plustek, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sintea Plustek, LLC's devices?

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

What risk classes do Sintea Plustek, LLC's devices fall under?

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

What are the newest devices from Sintea Plustek, LLC in the registry?

The most recently registered devices listed for Sintea Plustek, LLC include PLS-10090T57, PLS-48T5120, PLS-440T57 and PLS-550T56.

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