Identity
- Trade Name
- Calibration Adapter Unit OTD FDA UDI
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Model / Reference
- 1003 FDA UDI
Identifiers
- Catalog Number
- 30-154 FDA UDI
- Primary DI / UDI-DI
- 07350137521026 FDA UDI
- 510(k) Number
- K232140 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Electromagnetic/optical surgical navigation device tracking system
Calibration Adapter Unit OTD by Ortoma AB (Publ) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electromagnetic/optical surgical navigation device tracking system.
- Carto ENT — BIOSENSE WEBSTER (ISRAEL) LTD. · Class II
- Alignment Software Cranial with LITT — Brainlab AG · Class II
- TruDi™ Navigation System — BIOSENSE WEBSTER (ISRAEL) LTD. · Class II
- Cranial Guidance Software — Stryker Leibinger · Class II
- TruDi NAV Suction — ACCLARENT, INC. · Class II
- TruDi NAV Cable — ACCLARENT, INC. · Class II
- Cranial Guidance Software — Stryker Leibinger · Class II
- Hybrid Navigation Unit EM — Scopis GmbH · Class II
Cleared under the same submission
K232140 also covers:
- Attachment Adapter Fix OT — Ortoma AB (Publ)
- Attachment Adapter Twin OT — Ortoma AB (Publ)
- Calibration Adapter Unit OTD Emphasys — Ortoma AB (Publ)
- Inserter Adapter OTD — Ortoma AB (Publ)
- Inserter Adapter OTD Pinnacle Straight — Ortoma AB (Publ)
- Inserter Adapter OTD Straight — Ortoma AB (Publ)
- Measurement Screw 15 mm — Ortoma AB (Publ)
- Measurement Screw 8 mm — Ortoma AB (Publ)
- Measurement Screw Driver — Ortoma AB (Publ)
- OTS Hip — Ortoma AB (Publ)
- OTS Hip Guide Reusable Set Emphasys — Ortoma AB (Publ)
- OTS Hip Guide Reusable Set Pinnacle — Ortoma AB (Publ)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortoma AB (Publ)
Sources (1)
- FDA UDI 33833ae2-bcf4-46b7-8660-296753e72b62 34 fields · synced May 30, 2026