Identity
- Trade Name
- Op.n Tracker C FDA UDI
- Generic Name
- Surgical optical-tracking spatial marker, reusable FDA UDI
- Model / Reference
- A00065 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701311500889 FDA UDI
- 510(k) Number
- K242914 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Surgical optical-tracking spatial marker, reusable 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
No
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
Dry Heat Sterilization FDA UDI
Category: Surgical optical-tracking spatial marker, reusable
Op.n Tracker C by Ecential Robotics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical optical-tracking spatial marker, reusable.
- ARVIS ® — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
- ARVIS ® — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
- Paradigm — Proprio · Class II
- ARVIS ® — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
- ARVIS ® — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
- Paradigm — Proprio · Class II
- Paradigm — Proprio · Class II
- ARVIS ® — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
Cleared under the same submission
K242914 also covers:
- Navigation Instrument tray — ECENTIAL ROBOTICS
- Op.n Camera — ECENTIAL ROBOTICS
- Op.n ChoiceSpine App — ECENTIAL ROBOTICS
- Op.n Core — ECENTIAL ROBOTICS
- Op.n Perla TL Nav Software — ECENTIAL ROBOTICS
- Op.n Tracker A — ECENTIAL ROBOTICS
- Op.n Tracker B — ECENTIAL ROBOTICS
- Op.n Tracker D — ECENTIAL ROBOTICS
- Tracker fixation screw — ECENTIAL ROBOTICS
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 |
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Manufacturer
- Manufacturer
- Ecential Robotics
Sources (1)
- FDA UDI 21f1b45d-7d57-4ec3-ba31-8bc219cfbce0 33 fields · synced Jun 8, 2026