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FDA 510(k)

Mont Blanc and Mont Blanc MIS Spinal Systems

K-Number: K161387 · 2016-08-04

ApplicantSpineway SA
Decision Date2016-08-04
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mont Blanc and Mont Blanc MIS Spinal Systems is a medical device manufactured by Spineway SA. It received FDA 510(k) clearance on 2016-08-04 under approval number K161387. 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 Mont Blanc and Mont Blanc MIS Spinal Systems?

Mont Blanc and Mont Blanc MIS Spinal Systems is a medical device that received FDA 510(k) clearance on 2016-08-04. It is manufactured by Spineway SA. The 510(k) number is K161387.

When was Mont Blanc and Mont Blanc MIS Spinal Systems approved by the FDA?

Mont Blanc and Mont Blanc MIS Spinal Systems received FDA 510(k) clearance on 2016-08-04, under approval number K161387.

What company makes Mont Blanc and Mont Blanc MIS Spinal Systems?

Mont Blanc and Mont Blanc MIS Spinal Systems is manufactured by Spineway SA.

What is the FDA product code for Mont Blanc and Mont Blanc MIS Spinal Systems?

The FDA product code for Mont Blanc and Mont Blanc MIS Spinal Systems is NKB.

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Other Devices by Spineway SA

K191726mont blanc & mont blanc MIS Spinal Systems

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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