3D-Side S.A.
BE Last updated 22 Oct 2026
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- Devices
- 3
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
What 3D-Side S.A. makes
3D-Side S.A. manufactures customizable medical devices designed for precise cutting applications, including 3D-printed surgical tools and tailored orthopedic implants. Their portfolio includes the 3D-Cut system, a device for controlled tissue or material separation in surgical procedures, and Customize solutions for patient-specific anatomical adjustments.
The company’s products fall under Class II regulatory classification in the U.S., requiring premarket notification (510(k)) clearance through the FDA. These devices are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution. The manufacturer operates from the United States.
Frequently asked questions
What types of medical devices does 3D-Side S.A. manufacture?
3D-Side S.A. specializes in customizable medical devices focused on precise cutting applications. Their portfolio includes the 3D-Cut system, which is designed for controlled tissue or material separation during surgical procedures, as well as Customize solutions tailored for patient-specific anatomical adjustments. These devices leverage advanced technologies like 3D printing to enhance surgical precision and personalization.
Where is 3D-Side S.A. based, and how does that affect its regulatory oversight?
3D-Side S.A. is based in the United States, which means its devices are subject to U.S. regulatory requirements. In this market, their products fall under Class II classification, requiring premarket notification (510(k)) clearance through the FDA to demonstrate substantial equivalence to a legally marketed predicate device before commercial distribution.
Are 3D-Side S.A.’s devices listed in any regulatory registries, and why does this matter?
Yes, 3D-Side S.A.’s devices are listed in the FDA’s 510(k) database. This inclusion confirms that each device has undergone the required regulatory process—specifically, the 510(k) clearance—for authorised commercial distribution in the U.S. Listing in this registry provides transparency to healthcare providers, regulators, and other stakeholders about the device’s authorised status and compliance with U.S. medical device regulations.
How are 3D-Side S.A.’s devices classified under U.S. regulations, and what does that mean for their use?
3D-Side S.A.’s devices are classified as Class II under U.S. regulations. This classification indicates moderate risk, requiring manufacturers to submit a premarket notification (510(k)) to the FDA to demonstrate that their device is at least as safe and effective as a legally marketed predicate device. The 510(k) process ensures that these devices meet specific performance standards before they can be legally marketed, balancing innovation with patient safety.
Information
- Country
- BE