Ortoma AB

Sweden SE-MF-000034945 Last updated 22 Oct 2026

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Devices: 10
Registries: EUDAMEDFDA 510(k)
FDA recalls: 11 ongoing

Catalogue10

OTS™ Medizinisches elektrisches Set Ref 30-230

Class I EUDAMED Active
OTS Hip Ref K261852

Class II FDA 510(k) Active
OTS™ Computer- und Kameraständer Ref 30-225

Class I EUDAMED Active
OTS™ Medizinisches elektrisches System Ref 30-226

Class I EUDAMED Active
OTS™ Tracer CB Ref 30-153

Class I EUDAMED Active
OTS™ Hüftführungssystem Ref 30-101

Class IIb EUDAMED Active
OTS™ Tracer PT Ref 30-152

Class I EUDAMED Active
OTS Hip Ref K250086

Class II FDA 510(k) Active
Ortoma Treatment Solution - OTS Ref K181449

Class II FDA 510(k) Active
OTS Hip Ref K232140

Class II FDA 510(k) Active

FDA recalls1

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

2025
- 28 Jul 2025 Z-2615-2025 Class II Ongoing Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.

Information

Country: Sweden
Address: 3, Falkenbergsgatan, Gothenburg, Sweden
Website: www.ortoma.com
Email: [email protected]
EUDAMED SRN: SE-MF-000034945