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FDA 510(k)

Rotium Bioresorbable Wick

K-Number: K183236 · 2019-03-11

ApplicantNanofiber Solutions, LLC
Decision Date2019-03-11
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Rotium Bioresorbable Wick is the device name listed in this FDA 510(k) record. The listed applicant is Nanofiber Solutions, LLC. It received FDA 510(k) clearance on 2019-03-11 under 510(k) number K183236. 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 Rotium Bioresorbable Wick?

Rotium Bioresorbable Wick is a medical device that received FDA 510(k) clearance on 2019-03-11. The listed applicant is Nanofiber Solutions, LLC. The 510(k) number is K183236.

When did Rotium Bioresorbable Wick receive FDA 510(k) clearance?

Rotium Bioresorbable Wick received FDA 510(k) clearance on 2019-03-11, under 510(k) number K183236.

Who is the listed applicant for Rotium Bioresorbable Wick?

The FDA 510(k) record lists Nanofiber Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rotium Bioresorbable Wick?

The FDA product code for Rotium Bioresorbable Wick is MAI.

Other records listing Nanofiber Solutions, LLC as applicant

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.

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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 GmbHK254055OSSIOfiber® 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.

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