Identity
- Trade Name
- OTS™ Tracer-Set EUDAMEDTracer Set FDA UDI
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Device Name
- OTS Tracers EUDAMED
- Model / Reference
- 30-199 EUDAMED1001 FDA UDI
Identifiers
- Catalog Number
- 30-199 FDA UDI
- Primary DI / UDI-DI
- 17350137520521 EUDAMEDFDA UDI
- Basic UDI-DI
- 735013752OTSTracersSP EUDAMED
- 510(k) Number
- K232140 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
- GMDN Term
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Electromagnetic/optical surgical navigation device tracking system
Tracer Set by Ortoma AB (Publ) — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 — 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)
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI fc18d58b-2041-4b8b-86c3-50d1378a6ddb 34 fields · synced Jul 16, 2026
- EUDAMED 0eb3a71c-5719-44a7-85a0-bfcb9ad3e815 61 fields · synced Jul 16, 2026