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)

The Acumed Wrist Fixation System - 2.4mm Screws

K-Number: K252356 · 2025-08-21

ApplicantAcumed, LLC
Decision Date2025-08-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Acumed Wrist Fixation System - 2.4mm Screws is the device name listed in this FDA 510(k) record. The listed applicant is Acumed, LLC. It received FDA 510(k) clearance on 2025-08-21 under 510(k) number K252356. 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 The Acumed Wrist Fixation System - 2.4mm Screws?

The Acumed Wrist Fixation System - 2.4mm Screws is a medical device that received FDA 510(k) clearance on 2025-08-21. The listed applicant is Acumed, LLC. The 510(k) number is K252356.

When did The Acumed Wrist Fixation System - 2.4mm Screws receive FDA 510(k) clearance?

The Acumed Wrist Fixation System - 2.4mm Screws received FDA 510(k) clearance on 2025-08-21, under 510(k) number K252356.

Who is the listed applicant for The Acumed Wrist Fixation System - 2.4mm Screws?

The FDA 510(k) record lists Acumed, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Acumed Wrist Fixation System - 2.4mm Screws?

The FDA product code for The Acumed Wrist Fixation System - 2.4mm Screws is HRS.

Other records listing Acumed, LLC 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.

K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsK251296The Acumed Wrist Fixation SystemK243624Acu-Sinch Knotless MiniK233311Acumed Wrist Plating SystemK230744Acumed Acutrak 3 Headless Compression Screw SystemK221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

View all 9 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.

↑