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FDA 510(k)

GII Spinal Fixation System

K-Number: K210306 · 2021-05-19

ApplicantColigne AG
Decision Date2021-05-19
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GII Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Coligne AG. It received FDA 510(k) clearance on 2021-05-19 under 510(k) number K210306. 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 GII Spinal Fixation System?

GII Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2021-05-19. The listed applicant is Coligne AG. The 510(k) number is K210306.

When did GII Spinal Fixation System receive FDA 510(k) clearance?

GII Spinal Fixation System received FDA 510(k) clearance on 2021-05-19, under 510(k) number K210306.

Who is the listed applicant for GII Spinal Fixation System?

The FDA 510(k) record lists Coligne AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GII Spinal Fixation System?

The FDA product code for GII Spinal Fixation System is NKB.

Other records listing Coligne AG 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.

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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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