Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MICRORAPTOR Knotless Suture Anchor

K-Number: K181746 · 2018-09-28

ApplicantSmith and Nephew, Inc.
Decision Date2018-09-28
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICRORAPTOR Knotless Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew, Inc.. It received FDA 510(k) clearance on 2018-09-28 under 510(k) number K181746. 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 Knotless Suture Anchor?

MICRORAPTOR Knotless Suture Anchor is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Smith and Nephew, Inc.. The 510(k) number is K181746.

When did MICRORAPTOR Knotless Suture Anchor receive FDA 510(k) clearance?

MICRORAPTOR Knotless Suture Anchor received FDA 510(k) clearance on 2018-09-28, under 510(k) number K181746.

Who is the listed applicant for MICRORAPTOR Knotless Suture Anchor?

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

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

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

Related Clinical Trials

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.

NCT03985839Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and HipCOMPLETEDNCT04552119Safety of Treatment of Shoulder RepairCOMPLETED

Other records listing Smith and Nephew, 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.

PMA P210034Implant, resorbable, for articular osteochondral repairK222501Regeneten Bioinductive ImplantK221740SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera HeadK183232Double ENDOBUTTON Fixation DeviceK180361MICRORAPTOR REGENESORB Suture Anchor

View all 8 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑