FDA 510(k)

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System

N.º K: K213328 · 2022-02-11

Fecha de decisión2022-02-11

Código de productoHSB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2022-02-11 under 510(k) number K213328. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System?

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System is a medical device that received FDA 510(k) clearance on 2022-02-11. The listed applicant is Stryker GmbH. The 510(k) number is K213328.

When did Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System receive FDA 510(k) clearance?

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System received FDA 510(k) clearance on 2022-02-11, under 510(k) number K213328.

Who is the listed applicant for Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System?

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

What is the FDA product code for Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System?

The FDA product code for Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System is HSB.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Stryker GmbH como solicitante

K261481Pangea Femur Reconstruction System K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System K253202Hoffmann LRF System K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System K250163Sistema de Clavo Retrogrado T2 Alpha Fémur K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System

Ver todos los 53 dispositivos →

Dispositivos relacionados (Código: HSB)

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbH K253080Sistema de Clavo Femoral AND Medical (PFNA01); Sistema de Clavo Femoral AND Medical (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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.