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FDA 510(k)

Spine Navigation and Robotic-Assistance Device

K-Number: K233228 · 2024-06-14

ApplicantEcential Robotics
Decision Date2024-06-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spine Navigation and Robotic-Assistance Device is the device name listed in this FDA 510(k) record. The listed applicant is Ecential Robotics. It received FDA 510(k) clearance on 2024-06-14 under 510(k) number K233228. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spine Navigation and Robotic-Assistance Device?

Spine Navigation and Robotic-Assistance Device is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Ecential Robotics. The 510(k) number is K233228.

When did Spine Navigation and Robotic-Assistance Device receive FDA 510(k) clearance?

Spine Navigation and Robotic-Assistance Device received FDA 510(k) clearance on 2024-06-14, under 510(k) number K233228.

Who is the listed applicant for Spine Navigation and Robotic-Assistance Device?

The FDA 510(k) record lists Ecential Robotics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spine Navigation and Robotic-Assistance Device?

The FDA product code for Spine Navigation and Robotic-Assistance Device is OLO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05565131Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine SurgeryCOMPLETEDNCT07325578U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK ProceduresRECRUITINGNCT07574762Total Knee Arthroplasty With Personalized Implantation: Computer Navigation-Assisted Surgery Versus Robotic-Assisted SurgeryRECRUITING

Other records listing Ecential Robotics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261113Op.n™ Spine Navigation and Robotic GuidanceK242914Op.n(TM) NavigationK231886SURGIVISIO DeviceK221028SURGIVISIO DeviceK220946SURGIVISIO DeviceK220627SURGIVISIO Device

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Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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