Op.n Spine Navigation and Robotic Guidance
Ecential Robotics · K261113
FDA-authorized Predetermined Change Control Plan
- Company
- Ecential Robotics
- 510(k)/De Novo #
- K261113
- Decision date
- 2026-07-22
- Panel
- Neurology
- Pathway
- 510(k)
- Category
- Non-AI
- PCCP type
- Compatibility expansion
- Monitoring commitment
- Not stated
What this PCCP covers. Permits compatibility expansion to additional hardware
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- K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.2026-01-11AI hardwareRetraining
- K251936Ceribell Delirium Monitor SystemCeribell, Inc.2025-12-08AI/SaMDRetraining
- K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.2025-11-21AI/SaMDRetraining
- K251519RelieVRx (Pico G3)Appliedvr2025-08-13Non-AIHardware
- K243558Canvas DxCognoa, Inc.2025-04-11AI/SaMDRetraining
Want the monitoring teardown?
We read the PCCP for Op.n Spine Navigation and Robotic Guidance, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.