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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 the device name listed in this FDA 510(k) record. The listed applicant is Republic Spine, LLC. It received FDA 510(k) clearance on 2021-09-27 under 510(k) 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. The listed applicant is Republic Spine, LLC. The 510(k) number is K212028.

When did Dark Star Navigation Instrument System receive FDA 510(k) clearance?

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

Who is the listed applicant for Dark Star Navigation Instrument System?

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

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

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

Other records listing Republic Spine, LLC 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.

K223096Dark Star Deformity Pedicle Screw SystemK201420Republic Spine Dark Star Spinal SystemK190398Republic Spine Restore Intervertebral Body Fusion SystemK190889Republic Spine Restore Cervical Interbody Fusion SystemK181495Republic Spine Dark Star Spinal System

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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