FDA 510(k)

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

Número K: K251132 · 2025-07-14

Data da decisão2025-07-14

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws is the device name listed in this FDA 510(k) record. The listed applicant is Acumed, LLC. It received FDA 510(k) clearance on 2025-07-14 under 510(k) number K251132. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Acumed, LLC. The 510(k) number is K251132.

When did The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws receive FDA 510(k) clearance?

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

Who is the listed applicant for The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws?

The FDA 510(k) record lists Acumed, LLC as the applicant. This does not by itself establish the device manufacturer.

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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Outros registros que listam Acumed, LLC como candidato(a)

K252356The Acumed Wrist Fixation System - 2.4mm Screws K251296The Acumed Wrist Fixation System K243624Acu-Sinch Knotless Mini K233311Sistema de Placa de Pulso Acumed K230744Acumed Acutrak 3 Headless Compression Screw System K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

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Dispositivos Relacionados (Código: HRS)

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim Sirketi K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

Fonte oficial

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