FDA 510(k)

PASS LP Spinal System, CD Horizon Spinal System

K-Number: K213281 · 2022-01-05

Decision Date2022-01-05

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PASS LP Spinal System, CD Horizon Spinal System is a medical device manufactured by Medicrea International SA. It received FDA 510(k) clearance on 2022-01-05 under approval 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. It is manufactured by Medicrea International SA. The 510(k) number is K213281.

When was PASS LP Spinal System, CD Horizon Spinal System approved by the FDA?

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

What company makes PASS LP Spinal System, CD Horizon Spinal System?

PASS LP Spinal System, CD Horizon Spinal System is manufactured by Medicrea International SA.

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.

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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.