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FDA 510(k)

mont blanc & mont blanc MIS Spinal Systems

K-Number: K191726 · 2019-09-12

ApplicantSpineway SA
Decision Date2019-09-12
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

mont blanc & mont blanc MIS Spinal Systems is a medical device manufactured by Spineway SA. It received FDA 510(k) clearance on 2019-09-12 under approval number K191726. 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 & mont blanc MIS Spinal Systems?

mont blanc & mont blanc MIS Spinal Systems is a medical device that received FDA 510(k) clearance on 2019-09-12. It is manufactured by Spineway SA. The 510(k) number is K191726.

When was mont blanc & mont blanc MIS Spinal Systems approved by the FDA?

mont blanc & mont blanc MIS Spinal Systems received FDA 510(k) clearance on 2019-09-12, under approval number K191726.

What company makes mont blanc & mont blanc MIS Spinal Systems?

mont blanc & mont blanc MIS Spinal Systems is manufactured by Spineway SA.

What is the FDA product code for mont blanc & mont blanc MIS Spinal Systems?

The FDA product code for mont blanc & mont blanc MIS Spinal Systems is NKB.

Related Clinical Trials

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Other Devices by Spineway SA

K161387Mont Blanc and Mont Blanc MIS Spinal Systems

Related Devices (Code: NKB)

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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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