Data / Medical devices / Netherlands / Inpakomed
Inpakomed: FDA-registered device maker in Assendelft Noord-Holland, Netherlands, 1 510(k) clearance
Inpakomed is registered with the FDA (registration 3010593798) in Assendelft Noord-Holland, Netherlands. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 28, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010593798
- Address
- Industrieweg 13 a, Assendelft Noord-Holland, Netherlands, 1566JN
- Owner or operator
- Inpakomed (10045297)
- Roles
- Repackager or relabeler
- First device listed
- April 7, 2026
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sacroiliac Joint Fixation | OUR | 2 | Repackager or relabeler | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| January 28, 2026 | K252834 | Sacroiliac Joint Truss System (SJTS) | OUR | Substantially Equivalent | 4Web Medical | accessdata.fda.gov |
Compare with other makers
Updated January 28, 2026. 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.