Data / Medical devices / Sweden / Integrum AB
Integrum AB: FDA-registered device maker in Molndal Vastra Gotaland, Sweden, 1 PMA approval
Integrum AB is registered with the FDA (registration 3011386779) in Molndal Vastra Gotaland, Sweden. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated December 18, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011386779
- Address
- Gemenskapens gata 9, Molndal Vastra Gotaland, Sweden, SE-431 53
- Owner or operator
- Integrum AB (10050627)
- Roles
- Exporter to the US, Specification developer
- First device listed
- January 24, 2022
- Registered through
- 2026
- Brand names listed
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees | PJY | 3 | Exporter to the US, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 18, 2020 | P190009 | OPRA Implant System | PJY | 11 | April 15, 2026 | accessdata.fda.gov |
Compare with other makers
Updated April 15, 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.