FDA 510(k)

BPS - Bone Fragment Fixation Plates, Screws and Washers

Número K: K250055 · 2025-02-06

Data da decisão2025-02-06

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

BPS - Bone Fragment Fixation Plates, Screws and Washers is the device name listed in this FDA 510(k) record. The listed applicant is Orthonovis, Inc.. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K250055. 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 BPS - Bone Fragment Fixation Plates, Screws and Washers?

BPS - Bone Fragment Fixation Plates, Screws and Washers is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is Orthonovis, Inc.. The 510(k) number is K250055.

When did BPS - Bone Fragment Fixation Plates, Screws and Washers receive FDA 510(k) clearance?

BPS - Bone Fragment Fixation Plates, Screws and Washers received FDA 510(k) clearance on 2025-02-06, under 510(k) number K250055.

Who is the listed applicant for BPS - Bone Fragment Fixation Plates, Screws and Washers?

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

What is the FDA product code for BPS - Bone Fragment Fixation Plates, Screws and Washers?

The FDA product code for BPS - Bone Fragment Fixation Plates, Screws and Washers is HRS.

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Outros registros que listam Orthonovis, Inc. como candidato(a)

K252758Cannulated Screw and Kirschner (K wire) System K250498BPS Wrist Fracture System K242343BPS Wrist Fracture System K213905ONX Large External Fixation System

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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