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Sign in to claim this brandSintea Plustek, LLC
US
Last updated May 23, 2026
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.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sintea Plustek, LLC manufacture?
Sintea Plustek, LLC specializes in spinal and orthopaedic hardware. Their product portfolio includes trans-facet screws for internal spinal fixation, non-bioabsorbable spinal plates, metallic spinal fusion cages (both interbody and standalone), endoscopic-access dilators for minimally invasive procedures, and orthopaedic bone wires. These devices are designed for skeletal stabilization and spinal surgery applications.
Where is Sintea Plustek, LLC based?
Sintea Plustek, LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, particularly for FDA-monitored products.
Are Sintea Plustek, LLC’s devices listed in any regulatory registries?
Yes, Sintea Plustek, LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices for regulatory, safety, and market surveillance purposes, ensuring transparency in the supply chain.
How are Sintea Plustek, LLC’s devices classified under FDA regulations?
Sintea Plustek, LLC’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risks.
What distinguishes Sintea Plustek, LLC’s spinal fixation systems from other manufacturers?
Sintea Plustek, LLC’s spinal fixation systems are designed with a focus on internal stability and minimally invasive techniques. Their portfolio includes both sterile and non-sterile devices, such as trans-facet screws and metallic fusion cages, which cater to different surgical needs. The company’s offerings also extend to endoscopic tools, like single-use dilators, which support less invasive procedures compared to traditional open surgeries.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (874)
Page 16 of 18| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pls | PLS-930T57 | FDA UDI | Class II | Active |
| Pls | PLS-1080T58 | FDA UDI | Class II | Active |
| Pls | PLS-6065T56 | FDA UDI | Class II | Active |
| Acp | ACP-03T524 | FDA UDI | Class II | Active |
| Pls | PLS-65T56 | FDA UDI | Class II | Active |
| Pls | PLS-05T57 | FDA UDI | Class II | Active |
| Pls | PLS-63T56 | FDA UDI | Class II | Active |
| Pls | PLS-07T56 | FDA UDI | Class II | Active |
| Spider Kolibri | SPS-26S540 | FDA UDI | Class II | Active |
| Spider | SPS25S420 | FDA UDI | Class I | Active |
| Pls | PLS-12T55 | FDA UDI | Class II | Active |
| Pls | PLS-460T55 | FDA UDI | Class II | Active |
| Pls | PLS-550T55 | FDA UDI | Class II | Active |
| Pls | PLS-10080T56 | FDA UDI | Class II | Active |
| Pls | PLS-6070T540 | FDA UDI | Class II | Active |
| Pls | PLS-145T56 | FDA UDI | Class II | Active |
| Dsc | DSC-45PK1 | FDA UDI | Class II | Active |
| Pls | PLS-735T55 | FDA UDI | Class II | Active |
| Pls | PLS-445T55 | FDA UDI | Class II | Active |
| Spider Kolibri | SPS-27S550 | FDA UDI | Class II | Active |
| Pls | PLS-65T55 | FDA UDI | Class II | Active |
| Pls | PLS-150T327 | FDA UDI | Class II | Active |
| Acp | ACP-02T513 | FDA UDI | Class II | Active |
| Pls | PLS-150T537 | FDA UDI | Class II | Active |
| Pls | PLS-445T57 | FDA UDI | Class II | Active |
| Pls | PLS-655T56 | FDA UDI | Class II | Active |
| Pls | PLS-545T58 | FDA UDI | Class II | Active |
| Pls | PLS-10040T540 | FDA UDI | Class II | Active |
| Pls | PLS-535T55 | FDA UDI | Class II | Active |
| Dsc | DSC-41T51 | FDA UDI | Class II | Active |
| Pls | PLS-16T57 | FDA UDI | Class II | Active |
| Pls | PLS-10035T57 | FDA UDI | Class II | Active |
| Pls | PLS-49T5150 | FDA UDI | Class II | Active |
| Pls | PLS-530T58 | FDA UDI | Class II | Active |
| Pls | PLS-5100T57 | FDA UDI | Class II | Active |
| Pls | PLS-48T5300 | FDA UDI | Class II | Active |
| Pls | PLS-10045T55 | FDA UDI | Class II | Active |
| Pls | PLS-173T59 | FDA UDI | Class II | Active |
| Pls | PLS-13T54 | FDA UDI | Class II | Active |
| Pls | PLS-960T58 | FDA UDI | Class II | Active |
| Pls | PLS-950T56 | FDA UDI | Class II | Active |
| Pls | PLS-45T52 | FDA UDI | Class II | Active |
| Pls | PLS-10100T57 | FDA UDI | Class II | Active |
| Pls | PLS-49T5300 | FDA UDI | Class II | Active |
| Pls | PLS-48CC4 | FDA UDI | Class II | Active |
| Pls | PLS-5100T56 | FDA UDI | Class II | Active |
| Pls | PLS-745T57 | FDA UDI | Class II | Active |
| Pls | PLS-49T5200 | FDA UDI | Class II | Active |
| Pls | PLS-535T58 | FDA UDI | Class II | Active |
| Pls | PLS-10085T56 | FDA UDI | Class II | Active |
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