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Sign in to claim this brandSINTEA USA, LLC
US
Last updated May 27, 2026
What SINTEA USA, LLC makes
Sintea USA, LLC manufactures bone-screw internal spinal fixation systems with rod-based constructs, designed for surgical stabilization of the spine. These devices are intended for use in procedures requiring internal fixation to support spinal segments.
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. The manufacturer operates within 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 USA, LLC manufacture?
Sintea USA, LLC specializes in bone-screw internal spinal fixation systems with rod-based constructs. These devices are specifically designed for surgical stabilization of the spine, providing internal fixation to support spinal segments during procedures.
Where is Sintea USA, LLC based?
Sintea USA, LLC is based in the United States. The company operates within the U.S. market, focusing on the development and manufacturing of its spinal fixation devices.
Which regulatory registries list Sintea USA, LLC’s devices?
Sintea USA, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability.
How are Sintea USA, LLC’s devices classified under U.S. regulations?
Sintea USA, LLC’s bone-screw internal spinal fixation systems are classified as Class II medical devices under U.S. regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- sinteausa.com
- —
- —
- [email protected]
- Phone
- 3054906850
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 079917057
Catalogue (18)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pls | PLS-845T56 | FDA UDI | Class II | Active |
| Pls | PLS-545T540 | FDA UDI | Class II | Active |
| Pls | PLS-845T57 | FDA UDI | Class II | Active |
| Pls | PLS-540T55 | FDA UDI | Class II | Active |
| Pls | PLS-850T57 | FDA UDI | Class II | Active |
| Pls | PLS-530T56 | FDA UDI | Class II | Active |
| Pls | PLS-535T55 | FDA UDI | Class II | Active |
| Pls | PLS-555T56 | FDA UDI | Class II | Active |
| Pls | PLS-545T55 | FDA UDI | Class II | Active |
| Pls | PLS-845T58 | FDA UDI | Class II | Active |
| Pls | PLS-850T56 | FDA UDI | Class II | Active |
| Pls | PLS-550T55 | FDA UDI | Class II | Active |
| Pls | PLS-530T57 | FDA UDI | Class II | Active |
| Pls | PLS-535T57 | FDA UDI | Class II | Active |
| Pls | PLS-530T540 | FDA UDI | Class II | Active |
| Pls | PLS-855T58 | FDA UDI | Class II | Active |
| Pls | PLS-540T540 | FDA UDI | Class II | Active |
| Pls | PLS-535T540 | FDA UDI | Class II | Active |
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