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FDA 510(k)

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

K-Number: K251132 · 2025-07-14

ApplicantAcumed, LLC
Decision Date2025-07-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws is a medical device manufactured by Acumed, LLC. It received FDA 510(k) clearance on 2025-07-14 under approval number K251132. 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 - Plates; The Acumed Wrist Fixation System - Screws?

The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws is a medical device that received FDA 510(k) clearance on 2025-07-14. It is manufactured by Acumed, LLC. The 510(k) number is K251132.

When was The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws approved by the FDA?

The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws received FDA 510(k) clearance on 2025-07-14, under approval number K251132.

What company makes The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws?

The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws is manufactured by Acumed, LLC.

What is the FDA product code for The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws?

The FDA product code for The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - 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 K252356The Acumed Wrist Fixation System - 2.4mm Screws

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Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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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