Identity
- Trade Name
- Op.n ChoiceSpine App FDA UDI
- Generic Name
- Robotic surgical navigation system application software FDA UDI
- Model / Reference
- L60018 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701311501497 FDA UDI
- 510(k) Number
- K242914 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Robotic surgical navigation system application software 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Robotic surgical navigation system application software
Op.n ChoiceSpine App by Ecential Robotics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical navigation system application software.
- 360CAS — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
- 360CAS — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
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- OMNIBotics — OMNIlife science, Inc. · Class II
- ROSA Partial Knee Software V1.0 — Orthosoft Inc · Class II
- ORTHOMAP — Stryker Leibinger · Class II
- 360CAS — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
- Mako — MAKO Surgical Corp. · Class II
Cleared under the same submission
K242914 also covers:
- Navigation Instrument tray — ECENTIAL ROBOTICS
- Op.n Camera — 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 C — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ecential Robotics
Sources (1)
- FDA UDI d2b1afc3-52cd-44a6-936f-b38f835aeec0 33 fields · synced May 30, 2026