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FDA 510(k)

PASS LP Spinal System

K-Number: K190376 · 2019-05-02

ApplicantMedicrea International SA
Decision Date2019-05-02
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PASS LP Spinal System is a medical device manufactured by Medicrea International SA. It received FDA 510(k) clearance on 2019-05-02 under approval number K190376. 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?

PASS LP Spinal System is a medical device that received FDA 510(k) clearance on 2019-05-02. It is manufactured by Medicrea International SA. The 510(k) number is K190376.

When was PASS LP Spinal System approved by the FDA?

PASS LP Spinal System received FDA 510(k) clearance on 2019-05-02, under approval number K190376.

What company makes PASS LP Spinal System?

PASS LP Spinal System is manufactured by Medicrea International SA.

What is the FDA product code for PASS LP Spinal System?

The FDA product code for PASS LP Spinal System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Medicrea International SA

K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System K160640PASS XS Spinal System K160698LigaPASS K161627PASS LP Spinal System K161149PASS OCT Spinal System K160756PASS OCT Spinal System

View all 21 devices →

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

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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