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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 a medical device manufactured by Gm Dos Reis Industria E Comerico Ltda.. It received FDA 510(k) clearance on 2023-08-02 under approval 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. It is manufactured by Gm Dos Reis Industria E Comerico Ltda.. The 510(k) number is K223114.

When was Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors approved by the FDA?

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

What company makes Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors?

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors is manufactured by Gm Dos Reis Industria E Comerico Ltda..

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

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

Other Devices by Gm Dos Reis Industria E Comerico Ltda.

K182718Mini and Micro Fragments Reconstruction System – GMReis K180626Pedimax II - Pedicular Screw Spinal System

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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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