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FDA 510(k)

ChoiceSpine Navigation System

K-Number: K220024 · 2022-07-06

ApplicantChoice Spine, LLC
Decision Date2022-07-06
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ChoiceSpine Navigation System is a medical device manufactured by Choice Spine, LLC. It received FDA 510(k) clearance on 2022-07-06 under approval number K220024. 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 ChoiceSpine Navigation System?

ChoiceSpine Navigation System is a medical device that received FDA 510(k) clearance on 2022-07-06. It is manufactured by Choice Spine, LLC. The 510(k) number is K220024.

When was ChoiceSpine Navigation System approved by the FDA?

ChoiceSpine Navigation System received FDA 510(k) clearance on 2022-07-06, under approval number K220024.

What company makes ChoiceSpine Navigation System?

ChoiceSpine Navigation System is manufactured by Choice Spine, LLC.

What is the FDA product code for ChoiceSpine Navigation System?

The FDA product code for ChoiceSpine Navigation System is OLO.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT06895187 Catheter Ablation Using a Novel Navigation and Imaging System NOT_YET_RECRUITING

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 Choice Spine, LLC

K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System K191367Harrier-SA Lumbar Interbody System K201643ChoiceSpine Tiger Shark Cervical Spacer System K211449Triton™ Sacroiliac Joint Fixation System K203311ChoiceSpine Blackhawk Ti Cervical Spacer System K203561ChoiceSpine Navigation System

View all 9 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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