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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 a medical device manufactured by Evolution Spine. It received FDA 510(k) clearance on 2025-08-18 under approval 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. It is manufactured by Evolution Spine. The 510(k) number is K250167.

When was Evolution Spine Navigation Instruments approved by the FDA?

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

What company makes Evolution Spine Navigation Instruments?

Evolution Spine Navigation Instruments is manufactured by Evolution Spine.

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

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

Related Clinical Trials

NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT04968990 Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT07518615 Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon RECRUITING

Other Devices by Evolution Spine

K212405EMERGE™ Anterior Cervical Plate System K220275EMERGE Anterior Cervical Plate System K223146EVOLUTION SPINE Interbody System K241846E3D™-C Interbody System K240368E3D™-A Interbody System K232432E3D™-A Interbody System

View all 8 devices →

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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