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FDA 510(k)

Remex Spine Surgery Navigation System II

K-Number: K233513 · 2024-05-01

ApplicantRemex Medical Corp.
Decision Date2024-05-01
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Remex Spine Surgery Navigation System II is a medical device manufactured by Remex Medical Corp.. It received FDA 510(k) clearance on 2024-05-01 under approval number K233513. 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 Remex Spine Surgery Navigation System II?

Remex Spine Surgery Navigation System II is a medical device that received FDA 510(k) clearance on 2024-05-01. It is manufactured by Remex Medical Corp.. The 510(k) number is K233513.

When was Remex Spine Surgery Navigation System II approved by the FDA?

Remex Spine Surgery Navigation System II received FDA 510(k) clearance on 2024-05-01, under approval number K233513.

What company makes Remex Spine Surgery Navigation System II?

Remex Spine Surgery Navigation System II is manufactured by Remex Medical Corp..

What is the FDA product code for Remex Spine Surgery Navigation System II?

The FDA product code for Remex Spine Surgery Navigation System II is OLO.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40866856 Prognostic value of nutritional risk assessment indices in patients with digestive system tumors. BMC cancer (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Remex Medical Corp.

K230783Anatase Spine Surgery Navigation System K243560Remex Spine Surgery Navigation Instrument K241625Anatase Navi Disposable Instrument K251315Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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