FDA 510(k)

ROP Resorbable Hemostasis Material

N.º K: K153095 · 2016-02-17

SolicitanteResorbable Orthopedic Products, LLC

Fecha de decisión2016-02-17

Código de productoMTJ

DecisiónSubstantially Equivalent

Resumen del dispositivo

ROP Resorbable Hemostasis Material is the device name listed in this FDA 510(k) record. The listed applicant is Resorbable Orthopedic Products, LLC. It received FDA 510(k) clearance on 2016-02-17 under 510(k) number K153095. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ROP Resorbable Hemostasis Material?

ROP Resorbable Hemostasis Material is a medical device that received FDA 510(k) clearance on 2016-02-17. The listed applicant is Resorbable Orthopedic Products, LLC. The 510(k) number is K153095.

When did ROP Resorbable Hemostasis Material receive FDA 510(k) clearance?

ROP Resorbable Hemostasis Material received FDA 510(k) clearance on 2016-02-17, under 510(k) number K153095.

Who is the listed applicant for ROP Resorbable Hemostasis Material?

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

What is the FDA product code for ROP Resorbable Hemostasis Material?

The FDA product code for ROP Resorbable Hemostasis Material is MTJ.

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

Dispositivos relacionados (Código: MTJ)

K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)Orthocon, Inc.K261439Permatage Flowable, Settable Hemostatic Bone PasteOrthocon, Inc.K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.K231386Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.K200452Meril-BonewaxM/s. Meril Endo Surgery Private Limited.

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.