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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 a medical device manufactured by GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2025-11-04 under approval 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. It is manufactured by GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K252664.

When was GMReis Suture Anchors approved by the FDA?

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

What company makes GMReis Suture Anchors?

GMReis Suture Anchors is manufactured by GM Dos Reis Industria e Comercio Ltda..

What is the FDA product code for GMReis Suture Anchors?

The FDA product code for GMReis Suture Anchors is MBI.

Related Clinical Trials

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT06272201 Incisionless Suture Plications in a POSE2.0 Obesity Study NOT_YET_RECRUITING

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)

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Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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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