Data / Medical devices / Netherlands / Amber Implants BV
Amber Implants BV: FDA-registered device maker in The Hague Zuid-Holland, Netherlands, 1 510(k) clearance
Amber Implants BV is registered with the FDA (registration 3043534478) in The Hague Zuid-Holland, Netherlands. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043534478
- Address
- Prinses Beatrixlaan 546, 2595 BM, The Hague, The Hague Zuid-Holland, Netherlands, 2595BM
- Owner or operator
- Amber Implants (10094065)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
- First device listed
- January 26, 2026
- Registered through
- 2026
- Brand names listed
- VCFix® spinal system
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Bone, Vertebroplasty | NDN | 2 | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | 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 30, 2025 | K250637 | VCFix Spinal System | NDN | Substantially Equivalent | Amber Implants | accessdata.fda.gov |
Compare with other makers
Updated May 30, 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.