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Scien'Tx USA, Inc.

United StatesFDA applicant, unverified

Devices
12

What Scien'Tx USA, Inc. makes

Scien'Tx USA, Inc. manufactures spinal fixation and vertebral body replacement systems, including spinal stabilization devices like the ISOLOCK and ISOBAR systems, semi-rigid spinal implants, and anterior cervical and buttress plates. Their portfolio also includes vertebral body replacements such as the DAVANTIS/ANTELYS and SCIENT'X TRIBECA VBR, along with modifications to existing spinal connection systems.

These devices are classified as Class II under FDA regulations and are recorded in the 510(k) premarket notification process. The company operates from the United States.

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

Catalogue12

Newest first, rows 1-12 of 12

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  • Isolock Spinal System Ref K990721

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

  • Anterior Buttress Plate Ref K081548

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

  • Davantis/Antelys Vertebral Body Replacements Ref K053292

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

  • Isobar Spinal System Ref K013440

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

  • Isobar Spinal System Ref K013444

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

  • Isobar Semi-Rigid Spinal System Ref K991326

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

  • Isobar Spinal System Ref K013447

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

  • Modification To Isobar Spinal System Ref K020245

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

  • Scient'x Tribeca Vbr Ref K080588

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

  • Modification To Easys Transverse Connection Ref K031290

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

  • Anterior Cervical Plate System Ref K013439

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

  • Isobar Spinal System Ref K990118

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

Rows 1-12 of 12

Frequently asked questions

How many devices does Scien'Tx USA, Inc. have in the registry?

The registry currently lists 12 devices for Scien'Tx USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Scien'Tx USA, Inc.'s devices?

Among its 12 most recently registered devices, Scien'Tx USA, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Scien'Tx USA, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Scien'Tx USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Scien'Tx USA, Inc. in the registry?

The most recently registered devices listed for Scien'Tx USA, Inc. include ISOLOCK SPINAL SYSTEM, ANTERIOR BUTTRESS PLATE, DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS and ISOBAR SPINAL SYSTEM.

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