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Sign in to claim this brandSyntec Scientific Corp.
US
Last updated May 23, 2026
What Syntec Scientific Corp. makes
Syntec Scientific Corp. manufactures orthopaedic fixation devices, including intramedullary femur nails for long-bone stabilization, non-bioabsorbable bone screws, end-caps for bone nails, and non-bioabsorbable fixation plates. Their portfolio also includes reusable surgical procedure kits for orthopaedic procedures and specialized screws for bone reconstruction.
The company’s devices are regulated under FDA Class I and Class II classifications, with records available in the FDA’s 510(k) and UDI databases. Syntec Scientific Corp. 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 Syntec Scientific Corp. manufacture?
Syntec Scientific Corp. specializes in orthopaedic fixation devices. Their portfolio includes intramedullary femur nails for stabilizing long bones, non-bioabsorbable bone screws, end-caps for bone nails, non-bioabsorbable fixation plates, and reusable surgical procedure kits for orthopaedic procedures. These devices are designed to support bone healing and surgical reconstruction.
Where is Syntec Scientific Corp. based?
Syntec Scientific Corp. is headquartered in the United States. The company’s location influences its regulatory compliance with U.S. medical device standards, including FDA requirements.
Which regulatory registries list Syntec Scientific Corp.’s devices?
Syntec Scientific Corp.’s devices are documented in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track device classifications and compliance records, ensuring transparency for healthcare providers and regulators.
How are Syntec Scientific Corp.’s devices classified under FDA regulations?
Syntec Scientific Corp.’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices—like some orthopaedic fixation systems—have special controls to ensure safety and effectiveness. Classification depends on factors like device purpose, potential risks, and intended use.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (318)
Page 6 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Syntec Femoral Nail System | S880066N-14L | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880034L | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | T880034R | FDA UDI | Class II | Active |
| Syntec Osteo-plate and screw Fixation | 204816 | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880052N-12R | FDA UDI | Class II | Active |
| Syntec Osteo-plate and screw Fixation | 202838 | FDA UDI | Class II | Active |
| Syntec Recon Screw | S880081 | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880069N-14R | FDA UDI | Class II | Active |
| Syntec-Taichung Non-sterile Bone Plate and Screw Implants | 211030 | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880053L | FDA UDI | Class II | Active |
| Syntec End Cap | S880060-10 | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880039-9R | FDA UDI | Class II | Active |
| Syntec-Taichung Non-sterile Bone Plate and Screw Implants | 211036 | FDA UDI | Class II | Active |
| Syntec Osteo-plate and screw Fixation | 202824 | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880070N-14R | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | T880059N-13L | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | T880057R | FDA UDI | Class II | Active |
| Syntec Osteo-plate and screw Fixation | 202826 | FDA UDI | Class II | Active |
| Syntec Internal Hex Captured Screw | S880063 | FDA UDI | Class II | Active |
| Syntec Osteo-plate and screw Fixation | 204826 | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | T880038R | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880068N-14L | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880061N-13R | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | T880037L | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | T880054R | FDA UDI | Class II | Active |
| Syntec-Taichung Non-sterile Bone Plate and Screw Implants | 211032 | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880037L | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880064N-14L | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | T880057L | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880045R | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | T880049L | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880050L | FDA UDI | Class II | Active |
| Syntec Internal Hex Captured Screw | S880065 | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | T880048R | FDA UDI | Class II | Active |
| Syntec Recon Screw | S880082 | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880048L | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880056R | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | S880039R | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | T880040R | FDA UDI | Class II | Active |
| Syntec Osteo-plate and screw Fixation | 204840 | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | T880041R | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | T880036R | FDA UDI | Class II | Active |
| Syntec Osteo-plate and screw Fixation | 202810 | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | T880070 | FDA UDI | Class II | Active |
| Syntec Femoral Nail System | T880055R | FDA UDI | Class II | Active |
| Syntec Internal Hex Captured Screw | S880073 | FDA UDI | Class II | Active |
| Syntec Recon Screw | S880084 | FDA UDI | Class II | Active |
| Syntec Internal Hex Captured Screw | S880062 | FDA UDI | Class II | Active |
| Syntec Internal Hex Captured Screw | S880072 | FDA UDI | Class II | Active |
| Syntec Osteo-Plate And Screw Fixation | K092889 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Syntec Scientific Corp. CHANG HUA Changhua · TW FEI 3003414678