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FDA 510(k)

Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor

K-Number: K163672 · 2017-05-05

ApplicantNanova Biomaterials, Inc.
Decision Date2017-05-05
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor 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 2017-05-05 under 510(k) number K163672. 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 Screw-In Suture Anchor, Nanova Push-In Suture Anchor?

Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor is a medical device that received FDA 510(k) clearance on 2017-05-05. The listed applicant is Nanova Biomaterials, Inc.. The 510(k) number is K163672.

When did Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor receive FDA 510(k) clearance?

Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor received FDA 510(k) clearance on 2017-05-05, under 510(k) number K163672.

Who is the listed applicant for Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor?

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 Screw-In Suture Anchor, Nanova Push-In Suture Anchor?

The FDA product code for Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor 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.

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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