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Sign in to claim this brandNewdeal Sas
US
Last updated May 23, 2026
What Newdeal Sas makes
Newdeal Sas manufactures orthopaedic fixation devices, including non-bioabsorbable bone screws (both sterile and non-sterile), fixation plates, and non-adjustable bone staples. Their portfolio also includes reusable surgical tools such as drill guides, implant templates, and screwdrivers, as well as sterilization/disinfection containers for medical devices.
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. Newdeal Sas operates from 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 Newdeal Sas manufacture?
Newdeal Sas specializes in orthopaedic fixation devices, primarily focusing on non-bioabsorbable solutions. Their portfolio includes bone screws (both sterile and non-sterile), fixation plates, and non-adjustable bone staples. Additionally, they produce reusable surgical tools like drill guides, implant templates, and screwdrivers, as well as sterilization/disinfection containers for medical devices. These products are designed for orthopaedic procedures to stabilize bones and facilitate surgical precision.
Where is Newdeal Sas based, and what is its primary focus?
Newdeal Sas is based in the United States. The company’s primary focus is on developing and manufacturing orthopaedic fixation devices, particularly those used in bone stabilization and surgical assistance. Their product range supports orthopaedic surgeries by providing tools and implants tailored for specific anatomical needs, such as foot, hand, or limb fixation.
Which regulatory registries or databases list Newdeal Sas’s devices?
Newdeal Sas’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to identify and verify the devices used in medical procedures. The UDI system is a key resource for tracking specific products like their bone screws, fixation plates, and reusable surgical tools.
How are Newdeal Sas’s devices classified under FDA regulations?
Newdeal Sas’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, such as orthopaedic fixation hardware.
What distinguishes Newdeal Sas’s reusable surgical tools from their disposable orthopaedic implants?
Newdeal Sas’s reusable surgical tools, such as drill guides, implant templates, and screwdrivers, are designed for repeated use after proper sterilization or disinfection, which is why they include sterilization/disinfection containers in their portfolio. In contrast, their disposable orthopaedic implants—like non-bioabsorbable bone screws and fixation plates—are intended for single-use applications to ensure patient safety and sterility during surgery. The distinction lies in their intended lifecycle and regulatory handling.
AI-generated from registry data and not verified by a human reviewer.
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- US
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Catalogue (1137)
Page 23 of 23| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Surfix | 286620SND | FDA UDI | Class II | Active |
| Large Qwix® | 121976ND | FDA UDI | Class I | Unknown |
| Surfix | 285332ND | FDA UDI | Class II | Active |
| Surfix | POFND | FDA UDI | Class II | Active |
| Metis® | 139107ND | FDA UDI | Class I | Unknown |
| Large QWIX | 111770SND | FDA UDI | Class II | Active |
| Forefoot Solutions™ | 119903ND | FDA UDI | Class I | Active |
| Surfix | 285450SND | FDA UDI | Class II | Active |
| Large QWIX | 121535SND | FDA UDI | Class II | Active |
| Calcanea | 180335ND | FDA UDI | Class II | Unknown |
| Surfix® | 219545ND | FDA UDI | Class I | Active |
| Hallu®-FIX | 129933ND | FDA UDI | Class I | Unknown |
| Surfix | 286222ND | FDA UDI | Class II | Active |
| Large QWIX | 111555SND | FDA UDI | Class II | Active |
| Uni-Cp™ | 339920ND | FDA UDI | Class I | Unknown |
| Calcanea™ | 129139ND | FDA UDI | Class I | Unknown |
| Advansys® | 169003ND | FDA UDI | Class I | Active |
| Surfix | 286328ND | FDA UDI | Class II | Active |
| Forefoot Solutions™ | 159223ND | FDA UDI | Class I | Active |
| Advansys® | 169111ND | FDA UDI | Class I | Unknown |
| Surfix | 285324ND | FDA UDI | Class II | Active |
| SURFIX Alpha | 295336SND | FDA UDI | Class II | Active |
| Forefoot Solutions™ | 119017ND | FDA UDI | Class I | Active |
| SURFIX Alpha | 295116SND | FDA UDI | Class II | Active |
| Large QWIX | 121785SND | FDA UDI | Class II | Active |
| Large QWIX | 121805SND | FDA UDI | Class II | Active |
| Hallu®-FIX | 129930ND | FDA UDI | Class I | Active |
| Qwix Positioning Screw | K071639 | FDA 510(k) | Class II | Active |
| Basal Dorsal Plates | K063831 | FDA 510(k) | Class II | Active |
| Newdeal Interphalangeal Implant | K103623 | FDA 510(k) | Class II | Active |
| Newdeal Hallu Lock Plate System | K083154 | FDA 510(k) | Class II | Active |
| Newdeal Compression Plate | K070447 | FDA 510(k) | Class II | Active |
| Modified: Newdeal Hallu Plates | K093781 | FDA 510(k) | Class II | Active |
| Panta Nail (dia. 10mm), Panta Nail Xl | K091788 | FDA 510(k) | Class II | Active |
| Newdeal Compression Plate | K091609 | FDA 510(k) | Class II | Active |
| Newdeal Compression Plates | K093914 | FDA 510(k) | Class II | Active |
| Newdeal Tibiaxys System | K073375 | FDA 510(k) | Class II | Active |
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