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

[in effect]

United States · permit · permit

All Policies

Jurisdiction

United States

Classification

permit

Status

in effect

Effective Date

Jan 1, 2025

Primary Sources

1 audited

Statutory Scope & Summary

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.

Covered Sectors & Application Domains

Service & Cobot Robotics/

Regulatory Analysis & Inquiries

6 entries

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.

Primary Sources & Legal Instruments

1 document

https://www.biospace.com/ecential-robotics-receives-fda-clearance-for-its-surgical-robotic-platform-for-spine-surgery
https://www.biospace.com/ecential-robotics-receives-fda-clearance-for-its-surgical-robotic-platform-for-spine-surgery
Official Source