FDA Device Establishments · JSON-LD · Markdown
FEI 3014411622 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3014411622 |
|---|---|
| Owner / Operator | Ortoma AB (#10091322) |
| Address | Falkenbergsgatan 3, Gothenburg Vastra Gotaland, 41285, SE |
| Mandatory US Agent | MedTech Review, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | OLO |
| Regulation § (21 CFR) | 882.4560 |
| Proprietary names | OTS Hip Solution Emphasys; OTS Hip Solution Pinnacle; OTS Hip |
Source: openFDA. Public-domain (CC0).