FDA 510(k)

CD Horizon Spinal System

K-Number: K202771 · 2020-10-19

Decision Date2020-10-19

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CD Horizon Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2020-10-19 under 510(k) number K202771. 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 CD Horizon Spinal System?

CD Horizon Spinal System is a medical device that received FDA 510(k) clearance on 2020-10-19. The listed applicant is Medtronic. The 510(k) number is K202771.

When did CD Horizon Spinal System receive FDA 510(k) clearance?

CD Horizon Spinal System received FDA 510(k) clearance on 2020-10-19, under 510(k) number K202771.

Who is the listed applicant for CD Horizon Spinal System?

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

What is the FDA product code for CD Horizon Spinal System?

The FDA product code for CD Horizon Spinal System is NKB.

Related Clinical Trials

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Related Devices (Code: NKB)

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLC K261284Invictus® 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.O K253045“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.