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FDA 510(k)

Dark Star Navigation Instrument System

K-Number: K212028 · 2021-09-27

ApplicantRepublic Spine, LLC
Decision Date2021-09-27
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Dark Star Navigation Instrument System is a medical device manufactured by Republic Spine, LLC. It received FDA 510(k) clearance on 2021-09-27 under approval number K212028. 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 Dark Star Navigation Instrument System?

Dark Star Navigation Instrument System is a medical device that received FDA 510(k) clearance on 2021-09-27. It is manufactured by Republic Spine, LLC. The 510(k) number is K212028.

When was Dark Star Navigation Instrument System approved by the FDA?

Dark Star Navigation Instrument System received FDA 510(k) clearance on 2021-09-27, under approval number K212028.

What company makes Dark Star Navigation Instrument System?

Dark Star Navigation Instrument System is manufactured by Republic Spine, LLC.

What is the FDA product code for Dark Star Navigation Instrument System?

The FDA product code for Dark Star Navigation Instrument System is OLO.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease 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

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 Republic Spine, LLC

K181495Republic Spine Dark Star Spinal System K190398Republic Spine Restore Intervertebral Body Fusion System K190889Republic Spine Restore Cervical Interbody Fusion System K201420Republic Spine Dark Star Spinal System K223096Dark Star Deformity Pedicle Screw System

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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