Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CD Horizon™ Fenestrated Screw Set

K-Number: K193011 · 2020-01-10

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2020-01-10
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CD Horizon™ Fenestrated Screw Set 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 2020-01-10 under 510(k) number K193011. 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™ Fenestrated Screw Set?

CD Horizon™ Fenestrated Screw Set is a medical device that received FDA 510(k) clearance on 2020-01-10. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K193011.

When did CD Horizon™ Fenestrated Screw Set receive FDA 510(k) clearance?

CD Horizon™ Fenestrated Screw Set received FDA 510(k) clearance on 2020-01-10, under 510(k) number K193011.

Who is the listed applicant for CD Horizon™ Fenestrated Screw Set?

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™ Fenestrated Screw Set?

The FDA product code for CD Horizon™ Fenestrated Screw Set is NKB.

Other records listing Medtronic Sofamor Danek USA, Inc. 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.

PMA P000058Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinductionPMA P000054Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinductionK253011Catalyft PL Expandable Interbody SystemK261020Symmetrix™ L Spinal SystemK253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemK260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System

View all 82 devices →

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.

↑