_Regulation · Permit_

# FDA 510(k) Clearance: eCential Robotics Surgical Platform for Spine Surgery

Canonical ID: `0affffdd-1c42-4a7e-92e5-932fdf28662e`

- **Jurisdiction:** [United States](/locations/united-states.md) (id: `aa8b9c05-c836-4021-801f-59801970401e`)
- **Kind:** `permit`
- **Status (derived):** in_effect
- **Effective:** 2025-01-01

FDA cleared the eCential Robotics platform for intra-operative 2D and 3D imaging, navigation, and robotic guidance for spine surgery, with universal application across spinal procedures.

## Sources (1)

1. https://www.biospace.com/ecential-robotics-receives-fda-clearance-for-its-surgical-robotic-platform-for-spine-surgery · 2025-01-01

## Status history

- **in_effect** · 2025-01-01 · agent-recon
    - Initial ingestion

## Common questions

### What does FDA 510(k) Clearance: eCential Robotics Surgical Platform for Spine Surgery cover?

FDA cleared the eCential Robotics platform for intra-operative 2D and 3D imaging, navigation, and robotic guidance for spine surgery, with universal application across spinal procedures.

### Where does FDA 510(k) Clearance: eCential Robotics Surgical Platform for Spine Surgery apply?

FDA 510(k) Clearance: eCential Robotics Surgical Platform for Spine Surgery is recorded as a permitting requirement applying in United States on the DEPLOY registry.

### When did FDA 510(k) Clearance: eCential Robotics Surgical Platform for Spine Surgery take effect?

FDA 510(k) Clearance: eCential Robotics Surgical Platform for Spine Surgery is recorded as effective January 1, 2025 on the DEPLOY registry.

### Is FDA 510(k) Clearance: eCential Robotics Surgical Platform for Spine Surgery still in effect?

FDA 510(k) Clearance: eCential Robotics Surgical Platform for Spine Surgery is currently in effect and applies to covered operators in the named jurisdiction.

### What types of robots does FDA 510(k) Clearance: eCential Robotics Surgical Platform for Spine Surgery apply to?

FDA 510(k) Clearance: eCential Robotics Surgical Platform for Spine Surgery is recorded as applying to surgical on the DEPLOY registry.

### Which robot models on the DEPLOY registry fall under FDA 510(k) Clearance: eCential Robotics Surgical Platform for Spine Surgery?

8 robot models on the DEPLOY registry match the form-factor scope of FDA 510(k) Clearance: eCential Robotics Surgical Platform for Spine Surgery: ANOVO, Andromeda Surgical Robot, CORI, Carina and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.


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