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FDA 510(k)

Evolution Spine Navigation Instruments

K-Number: K250167 · 2025-08-18

ApplicantEvolution Spine
Decision Date2025-08-18
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Evolution Spine Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Evolution Spine. It received FDA 510(k) clearance on 2025-08-18 under 510(k) number K250167. 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 Evolution Spine Navigation Instruments?

Evolution Spine Navigation Instruments is a medical device that received FDA 510(k) clearance on 2025-08-18. The listed applicant is Evolution Spine. The 510(k) number is K250167.

When did Evolution Spine Navigation Instruments receive FDA 510(k) clearance?

Evolution Spine Navigation Instruments received FDA 510(k) clearance on 2025-08-18, under 510(k) number K250167.

Who is the listed applicant for Evolution Spine Navigation Instruments?

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

What is the FDA product code for Evolution Spine Navigation Instruments?

The FDA product code for Evolution Spine Navigation Instruments is OLO.

Other records listing Evolution Spine 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.

K262094E3D™-C Interbody SystemK260038E3D™-C Interbody SystemK241846E3D™-C Interbody SystemK240368E3D™-A Interbody SystemK232432E3D™-A Interbody SystemK223146EVOLUTION SPINE Interbody 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 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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