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FDA 510(k)

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors

K-Number: K223114 · 2023-08-02

ApplicantGm Dos Reis Industria E Comerico Ltda.
Decision Date2023-08-02
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Gm Dos Reis Industria E Comerico Ltda.. It received FDA 510(k) clearance on 2023-08-02 under 510(k) number K223114. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors?

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors is a medical device that received FDA 510(k) clearance on 2023-08-02. The listed applicant is Gm Dos Reis Industria E Comerico Ltda.. The 510(k) number is K223114.

When did Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors receive FDA 510(k) clearance?

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors received FDA 510(k) clearance on 2023-08-02, under 510(k) number K223114.

Who is the listed applicant for Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors?

The FDA 510(k) record lists Gm Dos Reis Industria E Comerico Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors?

The FDA product code for Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors is MBI.

Related Clinical Trials

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NCT04552119Safety of Treatment of Shoulder RepairCOMPLETED

Other records listing Gm Dos Reis Industria E Comerico Ltda. as applicant

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Related Devices (Code: MBI)

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.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

Official Source

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