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FDA 510(k)

Nano FortiFix® System

K-Number: K193211 · 2020-03-20

Decision Date2020-03-20
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Nano FortiFix® System is a medical device manufactured by Nanovis Spine, LLC. It received FDA 510(k) clearance on 2020-03-20 under approval number K193211. 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 Nano FortiFix® System?

Nano FortiFix® System is a medical device that received FDA 510(k) clearance on 2020-03-20. It is manufactured by Nanovis Spine, LLC. The 510(k) number is K193211.

When was Nano FortiFix® System approved by the FDA?

Nano FortiFix® System received FDA 510(k) clearance on 2020-03-20, under approval number K193211.

What company makes Nano FortiFix® System?

Nano FortiFix® System is manufactured by Nanovis Spine, LLC.

What is the FDA product code for Nano FortiFix® System?

The FDA product code for Nano FortiFix® System is NKB.

Other Devices by Nanovis Spine, LLC

Related Devices (Code: NKB)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.