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FDA 510(k)

Remex Spine Surgery Navigation Instrument

K-Number: K243560 · 2024-12-13

ApplicantRemex Medical Corp.
Decision Date2024-12-13
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Remex Spine Surgery Navigation Instrument is a medical device manufactured by Remex Medical Corp.. It received FDA 510(k) clearance on 2024-12-13 under approval number K243560. 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 Instrument?

Remex Spine Surgery Navigation Instrument is a medical device that received FDA 510(k) clearance on 2024-12-13. It is manufactured by Remex Medical Corp.. The 510(k) number is K243560.

When was Remex Spine Surgery Navigation Instrument approved by the FDA?

Remex Spine Surgery Navigation Instrument received FDA 510(k) clearance on 2024-12-13, under approval number K243560.

What company makes Remex Spine Surgery Navigation Instrument?

Remex Spine Surgery Navigation Instrument is manufactured by Remex Medical Corp..

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

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

Related Clinical Trials

NCT07608276 Impact of NOL - Nociception Level Index Intraoperative Monitoring on Perioperative Outcomes in Spine Surgery - a Quality Improvement Pilot NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06525896 Non-surgical Spinal Decompression Therapy and Outcomes ACTIVE_NOT_RECRUITING NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED

Related PubMed Literature

PMID: 37504879 Comparative Evaluation of Mineralized Bone Allografts for Spinal Fusion Surgery. Journal of functional biomaterials (2023)

Other Devices by Remex Medical Corp.

K230783Anatase Spine Surgery Navigation System K241625Anatase Navi Disposable Instrument K233513Remex Spine Surgery Navigation System II 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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