Identity
- Trade Name
- OTS Hip FDA UDI
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Model / Reference
- 1001 FDA UDI
Identifiers
- Catalog Number
- 10-105 FDA UDI
- Primary DI / UDI-DI
- 07350137521101 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Electromagnetic/optical surgical navigation device tracking system
OTS Hip by Ortoma AB (Publ) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electromagnetic/optical surgical navigation device tracking system.
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- 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 — 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 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 5c683d07-c2e3-4dbd-8637-1fa24afe13ac 34 fields · synced Jun 8, 2026