FDA 510(k)

Flap Fixator, Burr Hole Cover

K-Number: K192310 · 2020-06-03

Decision Date2020-06-03

Product CodeGXR

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Flap Fixator, Burr Hole Cover is a medical device manufactured by Ossaware Biotech Co., Ltd.. It received FDA 510(k) clearance on 2020-06-03 under approval number K192310. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flap Fixator, Burr Hole Cover?

Flap Fixator, Burr Hole Cover is a medical device that received FDA 510(k) clearance on 2020-06-03. It is manufactured by Ossaware Biotech Co., Ltd.. The 510(k) number is K192310.

When was Flap Fixator, Burr Hole Cover approved by the FDA?

Flap Fixator, Burr Hole Cover received FDA 510(k) clearance on 2020-06-03, under approval number K192310.

What company makes Flap Fixator, Burr Hole Cover?

Flap Fixator, Burr Hole Cover is manufactured by Ossaware Biotech Co., Ltd..

What is the FDA product code for Flap Fixator, Burr Hole Cover?

The FDA product code for Flap Fixator, Burr Hole Cover is GXR.

Related Devices (Code: GXR)

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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.