FDA 510(k)

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System

Número K: K163096 · 2017-03-31

Data da decisão2017-03-31

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Gpc Medical Limited. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K163096. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Gpc Medical Limited. The 510(k) number is K163096.

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

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System received FDA 510(k) clearance on 2017-03-31, under 510(k) number K163096.

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

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

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

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

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Outros registros que listam Gpc Medical Limited como candidato(a)

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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.

Fonte oficial

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