ORTOMA AB

FDA Device Registration & Listing · Gothenburg Vastra Gotaland, SE · Registration 3014411622

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014411622
FEI Number
3014411622
Entity Name
ORTOMA AB
City/State/Country
Gothenburg Vastra Gotaland, SE
Establishment Address
Falkenbergsgatan 3, Gothenburg Vastra Gotaland 41285, SE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Ortoma AB (Owner Number: 10091322)
Owner / Operator Contact Address
Falkenbergsgatan 3, Gothenburg, SE-O 41285, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K232140
PMA Number
N/A

All Registered Proprietary Names

OTS Hip OTS Hip Solution Emphasys OTS Hip Solution Pinnacle

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-08-30

Official Correspondent

No official correspondent registered.

US Agent Details

John Beasley Business: MedTech Review, LLC Email: john@medtechreview.com Phone: (702) 7236889

Related Public Records

Same Entity

Ortoma AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014411622. Last updated year: 2026. Please use registration number 3014411622 when referencing this establishment in official correspondence.
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