FDA 510(k)

MatrixRIB Fixation System

Número K: K161590 · 2016-11-03

Data da decisão2016-11-03

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MatrixRIB Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2016-11-03 under 510(k) number K161590. 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 MatrixRIB Fixation System?

MatrixRIB Fixation System is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K161590.

When did MatrixRIB Fixation System receive FDA 510(k) clearance?

MatrixRIB Fixation System received FDA 510(k) clearance on 2016-11-03, under 510(k) number K161590.

Who is the listed applicant for MatrixRIB Fixation System?

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

What is the FDA product code for MatrixRIB Fixation System?

The FDA product code for MatrixRIB Fixation System 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 Synthes (USA) Products, LLC como candidato(a)

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System K212943SyntheCel Dura Repair K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)K210408DePuy Synthes Variable Angle Locking Patella Plating System K210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System K201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm

Ver todos os 30 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.