# ORTOMA AB

FEI: 3014411622
Status: Active
Establishment types: Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Owner/operator: Ortoma AB (#10091322)

Address: Falkenbergsgatan 3, Gothenburg Vastra Gotaland, 41285, SE

Mandatory US Agent: MedTech Review, LLC

## Products

Total registered: 1
Top product codes: OLO
Regulation §: 882.4560

Proprietary names: OTS Hip Solution Emphasys, OTS Hip Solution Pinnacle, OTS Hip

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223014411622%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3014411622