Data / Medical devices / Belgium / 3d-Side
3d-Side: FDA-registered device maker in Mont Saint Guibert Brabant Wallon, Belgium, 4 510(k) clearances
3d-Side is registered with the FDA (registration 3013561205) in Mont Saint Guibert Brabant Wallon, Belgium. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 12, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013561205
- Address
- Rue Dumont, 5, Mont Saint Guibert Brabant Wallon, Belgium, 1435
- Owner or operator
- 3D-Side (10054501)
- Roles
- Manufacturer
- First device listed
- January 3, 2023
- Registered through
- 2026
- Brand names listed
- 3D-Ankle PLAN, 3D-Cut, ARCHER 3D, Archer PSI System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | 2 | Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Shoulder Arthroplasty Implantation System | QHE | 2 | Manufacturer | accessdata.fda.gov |
| Shoulder Prosthesis, Reverse Configuration | PHX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 12, 2025 | K243509 | Archer PSI System | QHE | Substantially Equivalent | 3D-Side | accessdata.fda.gov |
| August 3, 2022 | K221432 | Customize | QIH | Substantially Equivalent | 3D-Side S.A. | accessdata.fda.gov |
| March 16, 2022 | K213779 | Customize | QIH | Substantially Equivalent | 3D-Side S.A. | accessdata.fda.gov |
| November 29, 2021 | K212237 | 3D-Cut | PBF | Substantially Equivalent | 3D-Side S.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Shoulder Prosthesis, Reverse Configuration
- All makers of Shoulder Arthroplasty Implantation System
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- All makers of Automated Radiological Image Processing Software
- All makers of Screw, Fixation, Bone
- All makers of Orthopaedic Surgical Planning And Instrument Guides
Updated May 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.