FDA 510(k)

RibFix Blu Thoracic Fixation System

Número K: K212608 · 2022-04-22

Data da decisão2022-04-22

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

RibFix Blu Thoracic Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K212608. 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 RibFix Blu Thoracic Fixation System?

RibFix Blu Thoracic Fixation System is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Biomet Microfixation. The 510(k) number is K212608.

When did RibFix Blu Thoracic Fixation System receive FDA 510(k) clearance?

RibFix Blu Thoracic Fixation System received FDA 510(k) clearance on 2022-04-22, under 510(k) number K212608.

Who is the listed applicant for RibFix Blu Thoracic Fixation System?

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

What is the FDA product code for RibFix Blu Thoracic Fixation System?

The FDA product code for RibFix Blu Thoracic 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 Biomet Microfixation como candidato(a)

K261002Pectus Blu System K241709Pectus Blu Support Bar System K223199Broca 2.1 x 255mm, 22mm Parar K212782SternaLock Sternal Closure System K213712Pectus Support Bar System K213208Twist Drills

Ver todos os 13 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.