FDA 510(k)

Drill Guide; Drill Bit; Spine & Trauma Navigation

K-Number: K240701 · 2024-05-23

Decision Date2024-05-23

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Drill Guide; Drill Bit; Spine & Trauma Navigation is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K240701. 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 Drill Guide; Drill Bit; Spine & Trauma Navigation?

Drill Guide; Drill Bit; Spine & Trauma Navigation is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Brainlab AG. The 510(k) number is K240701.

When did Drill Guide; Drill Bit; Spine & Trauma Navigation receive FDA 510(k) clearance?

Drill Guide; Drill Bit; Spine & Trauma Navigation received FDA 510(k) clearance on 2024-05-23, under 510(k) number K240701.

Who is the listed applicant for Drill Guide; Drill Bit; Spine & Trauma Navigation?

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

What is the FDA product code for Drill Guide; Drill Bit; Spine & Trauma Navigation?

The FDA product code for Drill Guide; Drill Bit; Spine & Trauma Navigation is OLO.

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Other records listing Brainlab AG as applicant

K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout K252562Spine & Trauma Navigation Instruments K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PAD K243142Cranial 4Pi Immobilization K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)

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Related Devices (Code: OLO)

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation Centre K261205SPINEART Navigation Instrument SystemSpineart SA K262121Ion-L Navigated InstrumentsSurGenTec, LLC K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics K261852OTS 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.