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FDA 510(k)

MICRORAPTOR REGENESORB Suture Anchor

K-Number: K180361 · 2018-05-30

ApplicantSmith and Nephew, Inc.
Decision Date2018-05-30
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICRORAPTOR REGENESORB Suture Anchor is a medical device manufactured by Smith and Nephew, Inc.. It received FDA 510(k) clearance on 2018-05-30 under approval number K180361. 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 MICRORAPTOR REGENESORB Suture Anchor?

MICRORAPTOR REGENESORB Suture Anchor is a medical device that received FDA 510(k) clearance on 2018-05-30. It is manufactured by Smith and Nephew, Inc.. The 510(k) number is K180361.

When was MICRORAPTOR REGENESORB Suture Anchor approved by the FDA?

MICRORAPTOR REGENESORB Suture Anchor received FDA 510(k) clearance on 2018-05-30, under approval number K180361.

What company makes MICRORAPTOR REGENESORB Suture Anchor?

MICRORAPTOR REGENESORB Suture Anchor is manufactured by Smith and Nephew, Inc..

What is the FDA product code for MICRORAPTOR REGENESORB Suture Anchor?

The FDA product code for MICRORAPTOR REGENESORB Suture Anchor is MAI.

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 Smith and Nephew, Inc.

K163034SUTUREFIX Curved Suture Anchor K181746MICRORAPTOR Knotless Suture Anchor K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head K183232Double ENDOBUTTON Fixation Device K221740SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) K222501Regeneten Bioinductive Implant

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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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