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FDA 510(k)

SPINEART Navigation Instrument System

K-Number: K261205 · 2026-07-29

ApplicantSpineart SA
Decision Date2026-07-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPINEART Navigation Instrument System is the device name listed in this FDA 510(k) record. The listed applicant is Spineart SA. It received FDA 510(k) clearance on 2026-07-29 under 510(k) number K261205. 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 2026-07-29. The listed applicant is Spineart SA. The 510(k) number is K261205.

When did SPINEART Navigation Instrument System receive FDA 510(k) clearance?

SPINEART Navigation Instrument System received FDA 510(k) clearance on 2026-07-29, under 510(k) number K261205.

Who is the listed applicant for SPINEART Navigation Instrument System?

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

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

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

Other records listing Spineart SA 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.

K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemK254158SPINEART Navigation Instrument SystemK242933SPINEART Navigation Instrument SystemK242890SPINEART Navigation Instrument SystemK242589Scarlet® AL-TK241644SPINEART Navigation Instrument System

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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 CentreK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma ABK253921VERTICALE® Navigation InstrumentsSilony Medical GmbH

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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