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FDA 510(k)

PASS XS Spinal System

K-Number: K160640 · 2016-09-23

ApplicantMedicrea International SA
Decision Date2016-09-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PASS XS Spinal System is a medical device manufactured by Medicrea International SA. It received FDA 510(k) clearance on 2016-09-23 under approval number K160640. 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 XS Spinal System?

PASS XS Spinal System is a medical device that received FDA 510(k) clearance on 2016-09-23. It is manufactured by Medicrea International SA. The 510(k) number is K160640.

When was PASS XS Spinal System approved by the FDA?

PASS XS Spinal System received FDA 510(k) clearance on 2016-09-23, under approval number K160640.

What company makes PASS XS Spinal System?

PASS XS Spinal System is manufactured by Medicrea International SA.

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

The FDA product code for PASS XS 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

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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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