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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 a medical device manufactured by Nanova Biomaterials, Inc.. It received FDA 510(k) clearance on 2017-05-05 under approval 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. It is manufactured by Nanova Biomaterials, Inc.. The 510(k) number is K163672.

When was Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor approved by the FDA?

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

What company makes Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor?

Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor is manufactured by Nanova Biomaterials, Inc..

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.

Related Clinical Trials

NCT06636136 Transtibial Osseointegration RECRUITING

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Nanova Biomaterials, Inc.

K161174Nanova Interference Screw K151943Vas-Q-Clip K171330Nanova Sealant K172977Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel

Related Devices (Code: MAI)

K161174Nanova Interference ScrewNanova Biomaterials, Inc. K160804INTRAFIX(TM) Advance Tibial Fastener SystemMedos International SARL K151342Arthrex SwiveLock AnchorsArthrex, Inc. K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation

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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