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FDA 510(k)

Fiji Anchor

K-Number: K171228 · 2018-01-19

ApplicantSportwelding GmbH
Decision Date2018-01-19
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fiji Anchor is a medical device manufactured by Sportwelding GmbH. It received FDA 510(k) clearance on 2018-01-19 under approval number K171228. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fiji Anchor?

Fiji Anchor is a medical device that received FDA 510(k) clearance on 2018-01-19. It is manufactured by Sportwelding GmbH. The 510(k) number is K171228.

When was Fiji Anchor approved by the FDA?

Fiji Anchor received FDA 510(k) clearance on 2018-01-19, under approval number K171228.

What company makes Fiji Anchor?

Fiji Anchor is manufactured by Sportwelding GmbH.

What is the FDA product code for Fiji Anchor?

The FDA product code for Fiji Anchor is MAI.

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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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