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)

PASS LP™ Spinal System, CD Horizon™ Spinal System

K-Number: K213281 · 2022-01-05

ApplicantMedicrea International SA
Decision Date2022-01-05
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PASS LP™ Spinal System, CD Horizon™ Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International SA. It received FDA 510(k) clearance on 2022-01-05 under 510(k) number K213281. 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 PASS LP™ Spinal System, CD Horizon™ Spinal System?

PASS LP™ Spinal System, CD Horizon™ Spinal System is a medical device that received FDA 510(k) clearance on 2022-01-05. The listed applicant is Medicrea International SA. The 510(k) number is K213281.

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

PASS LP™ Spinal System, CD Horizon™ Spinal System received FDA 510(k) clearance on 2022-01-05, under 510(k) number K213281.

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

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

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

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

Other records listing Medicrea International SA 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 SystemK220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemK212005UNiD Spine AnalyzerK210470C-CURVE Interbody Fusion DeviceK200316UNiD IB3D ALIF

View all 27 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.

↑