FDA 510(k)

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System

N.º K: K190385 · 2019-08-08

Fecha de decisión2019-08-08

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2019-08-08 under 510(k) number K190385. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System?

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System is a medical device that received FDA 510(k) clearance on 2019-08-08. The listed applicant is In2bones USA, LLC. The 510(k) number is K190385.

When did CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System receive FDA 510(k) clearance?

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System received FDA 510(k) clearance on 2019-08-08, under 510(k) number K190385.

Who is the listed applicant for CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System?

The FDA product code for CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System is HRS.

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 In2bones USA, LLC como solicitante

K261154CoLink® & CoLag® Non-Sterile Screws K233089NeoSpan® Compression Implant System K231236IBS-B MIS Beveled Screw System K213698CoLink PCR Plating System K220260Hercules Syndesmosis Implant System K212872Avenger Radial Head System

Ver todos los 26 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.

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.