Data / Medical devices / Sweden / Ortoma AB
Ortoma AB: FDA-registered device maker in Gothenburg Vastra Gotaland, Sweden, 1 510(k) clearance
Ortoma AB is registered with the FDA (registration 3014411622) in Gothenburg Vastra Gotaland, Sweden. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 11, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014411622
- Address
- Falkenbergsgatan 3, Gothenburg Vastra Gotaland, Sweden, 41285
- Owner or operator
- Ortoma AB (10091322)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 30, 2024
- Registered through
- 2026
- Brand names listed
- OTS Hip, OTS Hip Solution Emphasys, OTS Hip Solution Pinnacle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 11, 2024 | K232140 | OTS Hip | OLO | Substantially Equivalent | Ortoma AB | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 28, 2025 | 97416 | Class II | Ongoing | Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer | Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. | accessdata.fda.gov |
Compare with other makers
Updated September 22, 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.