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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 a medical device manufactured by Acumed, LLC. It received FDA 510(k) clearance on 2025-08-21 under approval 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. It is manufactured by Acumed, LLC. The 510(k) number is K252356.

When was The Acumed Wrist Fixation System - 2.4mm Screws approved by the FDA?

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

What company makes The Acumed Wrist Fixation System - 2.4mm Screws?

The Acumed Wrist Fixation System - 2.4mm Screws is manufactured by Acumed, LLC.

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.

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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 K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws

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Related Devices (Code: HRS)

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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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