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FDA 510(k)

SPINEART Navigation Instrument System

K-Number: K183630 · 2019-06-10

ApplicantSpineart SA
Decision Date2019-06-10
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPINEART Navigation Instrument System is a medical device manufactured by Spineart SA. It received FDA 510(k) clearance on 2019-06-10 under approval number K183630. 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 SPINEART Navigation Instrument System?

SPINEART Navigation Instrument System is a medical device that received FDA 510(k) clearance on 2019-06-10. It is manufactured by Spineart SA. The 510(k) number is K183630.

When was SPINEART Navigation Instrument System approved by the FDA?

SPINEART Navigation Instrument System received FDA 510(k) clearance on 2019-06-10, under approval number K183630.

What company makes SPINEART Navigation Instrument System?

SPINEART Navigation Instrument System is manufactured by Spineart SA.

What is the FDA product code for SPINEART Navigation Instrument System?

The FDA product code for SPINEART Navigation Instrument System is OLO.

Related Clinical Trials

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Related PubMed Literature

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 Spineart SA

K231069PERLA® TL Posterior Thoraco-lumbar Fixation System K230583Tryptik Ti K242589Scarlet® AL-T K241644SPINEART Navigation Instrument System K241321Juliet® Ti LL Lumbar Interbody Device K240699SCARLET® AC-Ti

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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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