FDA 510(k)

Fiji Anchor

K-Number: K171228 · 2018-01-19

Decision Date2018-01-19

Product CodeMAI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Fiji Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Sportwelding GmbH. It received FDA 510(k) clearance on 2018-01-19 under 510(k) 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. The listed applicant is Sportwelding GmbH. The 510(k) number is K171228.

When did Fiji Anchor receive FDA 510(k) clearance?

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

Who is the listed applicant for Fiji Anchor?

The FDA 510(k) record lists Sportwelding GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fiji Anchor?

The FDA product code for Fiji Anchor is MAI.

Related Devices (Code: MAI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbH K254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

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.