FDA 510(k)

Pro-X1™ Trochanteric Nailing System

Número K: K221621 · 2023-03-06

Data da decisão2023-03-06

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pro-X1™ Trochanteric Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is X-Bolt Orthopedics. It received FDA 510(k) clearance on 2023-03-06 under 510(k) number K221621. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pro-X1™ Trochanteric Nailing System?

Pro-X1™ Trochanteric Nailing System is a medical device that received FDA 510(k) clearance on 2023-03-06. The listed applicant is X-Bolt Orthopedics. The 510(k) number is K221621.

When did Pro-X1™ Trochanteric Nailing System receive FDA 510(k) clearance?

Pro-X1™ Trochanteric Nailing System received FDA 510(k) clearance on 2023-03-06, under 510(k) number K221621.

Who is the listed applicant for Pro-X1™ Trochanteric Nailing System?

The FDA 510(k) record lists X-Bolt Orthopedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pro-X1™ Trochanteric Nailing System?

The FDA product code for Pro-X1™ Trochanteric Nailing System is HSB.

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

Dispositivos Relacionados (Código: HSB)

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbH K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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.