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)

Versalock Rib and Sternum Plates System

K-Number: K232829 · 2024-06-26

ApplicantGM Dos Reis Industria e Comercio Ltda.
Decision Date2024-06-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Versalock Rib and Sternum Plates System 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 2024-06-26 under 510(k) number K232829. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Versalock Rib and Sternum Plates System?

Versalock Rib and Sternum Plates System is a medical device that received FDA 510(k) clearance on 2024-06-26. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K232829.

When did Versalock Rib and Sternum Plates System receive FDA 510(k) clearance?

Versalock Rib and Sternum Plates System received FDA 510(k) clearance on 2024-06-26, under 510(k) number K232829.

Who is the listed applicant for Versalock Rib and Sternum Plates System?

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 Versalock Rib and Sternum Plates System?

The FDA product code for Versalock Rib and Sternum Plates System is HRS.

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 VersaflexK252664GMReis Suture AnchorsK243905Stitch Cerclage – Suture TapesK243740Versalock Upper Limb Plating System

View all 14 devices →

Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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.

↑