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FDA 510(k)

Dark Star Deformity Pedicle Screw System

K-Number: K223096 · 2023-05-26

ApplicantRepublic Spine, LLC
Decision Date2023-05-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dark Star Deformity Pedicle Screw 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 2023-05-26 under 510(k) number K223096. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dark Star Deformity Pedicle Screw System?

Dark Star Deformity Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Republic Spine, LLC. The 510(k) number is K223096.

When did Dark Star Deformity Pedicle Screw System receive FDA 510(k) clearance?

Dark Star Deformity Pedicle Screw System received FDA 510(k) clearance on 2023-05-26, under 510(k) number K223096.

Who is the listed applicant for Dark Star Deformity Pedicle Screw 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 Deformity Pedicle Screw System?

The FDA product code for Dark Star Deformity Pedicle Screw System is NKB.

Related Clinical Trials

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.

NCT05565131Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine SurgeryCOMPLETED

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.

K212028Dark Star Navigation Instrument 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: NKB)

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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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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