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FDA 510(k)

Acumed Wrist Plating System

K-Number: K233311 · 2024-04-22

ApplicantAcumed, LLC
Decision Date2024-04-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Acumed Wrist Plating System is a medical device manufactured by Acumed, LLC. It received FDA 510(k) clearance on 2024-04-22 under approval number K233311. 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 Acumed Wrist Plating System?

Acumed Wrist Plating System is a medical device that received FDA 510(k) clearance on 2024-04-22. It is manufactured by Acumed, LLC. The 510(k) number is K233311.

When was Acumed Wrist Plating System approved by the FDA?

Acumed Wrist Plating System received FDA 510(k) clearance on 2024-04-22, under approval number K233311.

What company makes Acumed Wrist Plating System?

Acumed Wrist Plating System is manufactured by Acumed, LLC.

What is the FDA product code for Acumed Wrist Plating System?

The FDA product code for Acumed Wrist Plating 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 K252356The Acumed Wrist Fixation System - 2.4mm Screws K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws

View all 9 devices →

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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