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FDA 510(k)

Nanova Interference Screw

K-Number: K161174 · 2016-11-03

ApplicantNanova Biomaterials, Inc.
Decision Date2016-11-03
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Nanova Interference Screw is the device name listed in this FDA 510(k) record. The listed applicant is Nanova Biomaterials, Inc.. It received FDA 510(k) clearance on 2016-11-03 under 510(k) number K161174. 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 Nanova Interference Screw?

Nanova Interference Screw is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Nanova Biomaterials, Inc.. The 510(k) number is K161174.

When did Nanova Interference Screw receive FDA 510(k) clearance?

Nanova Interference Screw received FDA 510(k) clearance on 2016-11-03, under 510(k) number K161174.

Who is the listed applicant for Nanova Interference Screw?

The FDA 510(k) record lists Nanova Biomaterials, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nanova Interference Screw?

The FDA product code for Nanova Interference Screw is MAI.

Other records listing Nanova Biomaterials, Inc. 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.

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 CorporationK252022OSSIOfiber® Interference ScrewOSSIO , Ltd.

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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