FDA 510(k)

GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System

N.º K: K230325 · 2024-10-10

Fecha de decisión2024-10-10

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Greens Surgicals Pvt. , Ltd.. It received FDA 510(k) clearance on 2024-10-10 under 510(k) number K230325. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System?

GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is Greens Surgicals Pvt. , Ltd.. The 510(k) number is K230325.

When did GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System receive FDA 510(k) clearance?

GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System received FDA 510(k) clearance on 2024-10-10, under 510(k) number K230325.

Who is the listed applicant for GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System?

The FDA 510(k) record lists Greens Surgicals Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System?

The FDA product code for GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is NKB.

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Otros registros que enlistan a Greens Surgicals Pvt. , Ltd. como solicitante

K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System

Dispositivos relacionados (Código: NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

Fuente oficial

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