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)

Arthrex 3.9mm Corkscrew Suture Anchor

K-Number: K193157 · 2019-12-12

ApplicantArthrex, Inc.
Decision Date2019-12-12
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex 3.9mm Corkscrew Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2019-12-12 under 510(k) number K193157. 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 Arthrex 3.9mm Corkscrew Suture Anchor?

Arthrex 3.9mm Corkscrew Suture Anchor is a medical device that received FDA 510(k) clearance on 2019-12-12. The listed applicant is Arthrex, Inc.. The 510(k) number is K193157.

When did Arthrex 3.9mm Corkscrew Suture Anchor receive FDA 510(k) clearance?

Arthrex 3.9mm Corkscrew Suture Anchor received FDA 510(k) clearance on 2019-12-12, under 510(k) number K193157.

Who is the listed applicant for Arthrex 3.9mm Corkscrew Suture Anchor?

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

What is the FDA product code for Arthrex 3.9mm Corkscrew Suture Anchor?

The FDA product code for Arthrex 3.9mm Corkscrew 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.

NCT05753891Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)TERMINATEDNCT06829667Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle InstabilityCOMPLETED

Other records listing Arthrex, 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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsK260624Arthrex Radial Head Replacement SystemK260018Arthrex FiberButtonK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemK253931Arthrex Bioabsorbable PushLock Suture AnchorsK254215Arthrex Beaming System

View all 173 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.

↑