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)

MAXXOS P.A.C.E. Foot & Ankle Plating System

K-Number: K251892 · 2025-09-08

ApplicantMaxxos Medical GmbH
Decision Date2025-09-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAXXOS P.A.C.E. Foot & Ankle Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Maxxos Medical GmbH. It received FDA 510(k) clearance on 2025-09-08 under 510(k) number K251892. 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 MAXXOS P.A.C.E. Foot & Ankle Plating System?

MAXXOS P.A.C.E. Foot & Ankle Plating System is a medical device that received FDA 510(k) clearance on 2025-09-08. The listed applicant is Maxxos Medical GmbH. The 510(k) number is K251892.

When did MAXXOS P.A.C.E. Foot & Ankle Plating System receive FDA 510(k) clearance?

MAXXOS P.A.C.E. Foot & Ankle Plating System received FDA 510(k) clearance on 2025-09-08, under 510(k) number K251892.

Who is the listed applicant for MAXXOS P.A.C.E. Foot & Ankle Plating System?

The FDA 510(k) record lists Maxxos Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXXOS P.A.C.E. Foot & Ankle Plating System?

The FDA product code for MAXXOS P.A.C.E. Foot & Ankle Plating System is HRS.

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.

↑