FDA 510(k)

NCB Plating System Distal Femur and Proximal Tibia

Número K: K192217 · 2019-09-13

Data da decisão2019-09-13

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

NCB Plating System Distal Femur and Proximal Tibia is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2019-09-13 under 510(k) number K192217. 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 NCB Plating System Distal Femur and Proximal Tibia?

NCB Plating System Distal Femur and Proximal Tibia is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Zimmer GmbH. The 510(k) number is K192217.

When did NCB Plating System Distal Femur and Proximal Tibia receive FDA 510(k) clearance?

NCB Plating System Distal Femur and Proximal Tibia received FDA 510(k) clearance on 2019-09-13, under 510(k) number K192217.

Who is the listed applicant for NCB Plating System Distal Femur and Proximal Tibia?

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

What is the FDA product code for NCB Plating System Distal Femur and Proximal Tibia?

The FDA product code for NCB Plating System Distal Femur and Proximal Tibia is HRS.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Zimmer GmbH como candidato(a)

K211047CoCr Head K200814Sistema de Unha Natural Affixus(R) Unha Humeral K200112Zimmer Hip Joint Replacement K193099Sistema de Ombro Anatômico K193050Fêmur Alloclassic Zweymuller SL, Fêmur Alloclassic Zweymuller SL com Desvio, Alloclassic Zweymuller SL K193030Avenir Muller Stem, Avenir Cemented Hip Stem

Ver todos os 19 dispositivos →

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

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.