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FDA 510(k)

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)

K-Number: K233951 · 2024-03-27

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2024-03-27
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2024-03-27 under 510(k) number K233951. 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 ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)?

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) is a medical device that received FDA 510(k) clearance on 2024-03-27. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K233951.

When did CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) receive FDA 510(k) clearance?

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) received FDA 510(k) clearance on 2024-03-27, under 510(k) number K233951.

Who is the listed applicant for CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)?

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

What is the FDA product code for CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)?

The FDA product code for CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) is NKB.

Other records listing Medtronic Sofamor Danek USA, Inc. as applicant

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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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