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FDA 510(k)

Paradigm All-Suture Anchor 1.8mm, White/Black #2

K-Number: K190333 · 2019-03-18

Decision Date2019-03-18
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Paradigm All-Suture Anchor 1.8mm, White/Black #2 is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2019-03-18 under approval number K190333. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Paradigm All-Suture Anchor 1.8mm, White/Black #2?

Paradigm All-Suture Anchor 1.8mm, White/Black #2 is a medical device that received FDA 510(k) clearance on 2019-03-18. It is manufactured by Conmed Corporation. The 510(k) number is K190333.

When was Paradigm All-Suture Anchor 1.8mm, White/Black #2 approved by the FDA?

Paradigm All-Suture Anchor 1.8mm, White/Black #2 received FDA 510(k) clearance on 2019-03-18, under approval number K190333.

What company makes Paradigm All-Suture Anchor 1.8mm, White/Black #2?

Paradigm All-Suture Anchor 1.8mm, White/Black #2 is manufactured by Conmed Corporation.

What is the FDA product code for Paradigm All-Suture Anchor 1.8mm, White/Black #2?

The FDA product code for Paradigm All-Suture Anchor 1.8mm, White/Black #2 is MBI.

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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.