FDA 510(k)

Medline ReNewal Reprocessed Stryker External Fixation Devices

N.º K: K163028 · 2016-12-28

SolicitanteSurgical Instrument Service and Savings, Inc.

Fecha de decisión2016-12-28

Código de productoJEC

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medline ReNewal Reprocessed Stryker External Fixation Devices is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2016-12-28 under 510(k) number K163028. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Medline ReNewal Reprocessed Stryker External Fixation Devices?

Medline ReNewal Reprocessed Stryker External Fixation Devices is a medical device that received FDA 510(k) clearance on 2016-12-28. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K163028.

When did Medline ReNewal Reprocessed Stryker External Fixation Devices receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Stryker External Fixation Devices received FDA 510(k) clearance on 2016-12-28, under 510(k) number K163028.

Who is the listed applicant for Medline ReNewal Reprocessed Stryker External Fixation Devices?

The FDA 510(k) record lists Surgical Instrument Service and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed Stryker External Fixation Devices?

The FDA product code for Medline ReNewal Reprocessed Stryker External Fixation Devices is JEC.

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 Surgical Instrument Service and Savings, Inc. como solicitante

K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer K252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter K250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter

Ver todos los 23 dispositivos →

Dispositivos relacionados (Código: JEC)

K203605SteriTrakArbutus Medical, Inc.K193256Sistema Anjon Bremer HaloAnjon Holdings, LLC K192465DigiFix Sterile KitVirak Orthopedics, LLC K181192PIP FixHand Biomechanics Lab, Inc.K171863Sistema Anjon Bremer HaloAnjon Holdings, LLC

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.