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FDA 510(k)

The Acumed Wrist Fixation System

K-Number: K251296 · 2025-06-18

ApplicantAcumed, LLC
Decision Date2025-06-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Acumed Wrist Fixation System is a medical device manufactured by Acumed, LLC. It received FDA 510(k) clearance on 2025-06-18 under approval number K251296. 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?

The Acumed Wrist Fixation System is a medical device that received FDA 510(k) clearance on 2025-06-18. It is manufactured by Acumed, LLC. The 510(k) number is K251296.

When was The Acumed Wrist Fixation System approved by the FDA?

The Acumed Wrist Fixation System received FDA 510(k) clearance on 2025-06-18, under approval number K251296.

What company makes The Acumed Wrist Fixation System?

The Acumed Wrist Fixation System is manufactured by Acumed, LLC.

What is the FDA product code for The Acumed Wrist Fixation System?

The FDA product code for The Acumed Wrist Fixation System is HRS.

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Other Devices by Acumed, LLC

K210750Acumed Clavicle Hook Plating System K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional K212990Acumed Ankle Syndesmosis Repair System K230744Acumed Acutrak 3 Headless Compression Screw System K233311Acumed Wrist Plating System K252356The Acumed Wrist Fixation System - 2.4mm Screws

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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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