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FDA 510(k)

Instruments for LINK MEGASYSTEM-C Family

K-Number: K190181 · 2019-10-25

ApplicantLinkBio Corp.
Decision Date2019-10-25
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Instruments for LINK MEGASYSTEM-C Family is a medical device manufactured by LinkBio Corp.. It received FDA 510(k) clearance on 2019-10-25 under approval number K190181. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Instruments for LINK MEGASYSTEM-C Family?

Instruments for LINK MEGASYSTEM-C Family is a medical device that received FDA 510(k) clearance on 2019-10-25. It is manufactured by LinkBio Corp.. The 510(k) number is K190181.

When was Instruments for LINK MEGASYSTEM-C Family approved by the FDA?

Instruments for LINK MEGASYSTEM-C Family received FDA 510(k) clearance on 2019-10-25, under approval number K190181.

What company makes Instruments for LINK MEGASYSTEM-C Family?

Instruments for LINK MEGASYSTEM-C Family is manufactured by LinkBio Corp..

What is the FDA product code for Instruments for LINK MEGASYSTEM-C Family?

The FDA product code for Instruments for LINK MEGASYSTEM-C Family is KRO.

Other Devices by LinkBio Corp.

K241470CORE Shoulder System

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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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