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FDA 510(k)

CD Horizon™ Spinal System and PASS LP™ Spinal System

K-Number: K220724 · 2022-04-08

ApplicantMedicrea International
Decision Date2022-04-08
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CD Horizon™ Spinal System and PASS LP™ Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K220724. 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 and PASS LP™ Spinal System?

CD Horizon™ Spinal System and PASS LP™ Spinal System is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is Medicrea International. The 510(k) number is K220724.

When did CD Horizon™ Spinal System and PASS LP™ Spinal System receive FDA 510(k) clearance?

CD Horizon™ Spinal System and PASS LP™ Spinal System received FDA 510(k) clearance on 2022-04-08, under 510(k) number K220724.

Who is the listed applicant for CD Horizon™ Spinal System and PASS LP™ Spinal System?

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

What is the FDA product code for CD Horizon™ Spinal System and PASS LP™ Spinal System?

The FDA product code for CD Horizon™ Spinal System and PASS LP™ Spinal System is NKB.

Other records listing Medicrea International 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.

K213659LigaPASS™ 2.0 Ligament Augmentation SystemK220810Infinity™ OCT System and PASS OCT Spinal SystemK212005UNiD Spine AnalyzerK213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemK210470C-CURVE Interbody Fusion DeviceK200316UNiD IB3D ALIF

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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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