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FDA 510(k)

GMReis Suture Anchors

K-Number: K252664 · 2025-11-04

ApplicantGM Dos Reis Industria e Comercio Ltda.
Decision Date2025-11-04
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMReis Suture Anchors is the device name listed in this FDA 510(k) record. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2025-11-04 under 510(k) number K252664. 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 GMReis Suture Anchors?

GMReis Suture Anchors is a medical device that received FDA 510(k) clearance on 2025-11-04. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K252664.

When did GMReis Suture Anchors receive FDA 510(k) clearance?

GMReis Suture Anchors received FDA 510(k) clearance on 2025-11-04, under 510(k) number K252664.

Who is the listed applicant for GMReis Suture Anchors?

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

What is the FDA product code for GMReis Suture Anchors?

The FDA product code for GMReis Suture Anchors is MBI.

Other records listing GM Dos Reis Industria e Comercio Ltda. 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.

K261406Versalock Proximal Tibial Plating SystemK260390Super Upper Limbs Versalock Plating SystemK254188Meniscus VersaflexK243905Stitch Cerclage – Suture TapesK243740Versalock Upper Limb Plating SystemK242998GMReis Ankle Plating System

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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

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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