Class Class II

The Acumed Wrist Fixation System – Plates; The Acumed Wrist Fixation System – Screws (K251132)

K251132 2025-07-14 Abbreviated
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Description

The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws by Acumed, LLC, an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251132
Clearance Date2025-07-14
Clearance TypeAbbreviated
Product CodeHRS
Regulation Number888.3030

Categories

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Predicate lineage for K251132

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. The Acumed Wrist Fixation System – Plates; The Acumed Wrist Fixation System – Screws (K251132) cites 0 predicate devices and is itself cited by 1 later device.

Later devices that cite this one as their predicate

Devices that cite K251132
K numberDeviceApplicantYear
K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC2025

Trace the full predicate network for K251132

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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