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FDA 510(k)

Republic Spine Dark Star Spinal System

K-Number: K201420 · 2021-03-05

ApplicantRepublic Spine, LLC
Decision Date2021-03-05
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Republic Spine Dark Star Spinal 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 2021-03-05 under 510(k) number K201420. 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 Republic Spine Dark Star Spinal System?

Republic Spine Dark Star Spinal System is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Republic Spine, LLC. The 510(k) number is K201420.

When did Republic Spine Dark Star Spinal System receive FDA 510(k) clearance?

Republic Spine Dark Star Spinal System received FDA 510(k) clearance on 2021-03-05, under 510(k) number K201420.

Who is the listed applicant for Republic Spine Dark Star Spinal 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 Republic Spine Dark Star Spinal System?

The FDA product code for Republic Spine Dark Star Spinal System is NKB.

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 SystemK212028Dark Star Navigation Instrument 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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