FDA 510(k)

SurgTech Interbody System

Número K: K152200 · 2016-03-25

Data da decisão2016-03-25

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SurgTech Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Surgtech, Inc.. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K152200. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SurgTech Interbody System?

SurgTech Interbody System is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is Surgtech, Inc.. The 510(k) number is K152200.

When did SurgTech Interbody System receive FDA 510(k) clearance?

SurgTech Interbody System received FDA 510(k) clearance on 2016-03-25, under 510(k) number K152200.

Who is the listed applicant for SurgTech Interbody System?

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

What is the FDA product code for SurgTech Interbody System?

The FDA product code for SurgTech Interbody System is MAX.

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Outros registros que listam Surgtech, Inc. como candidato(a)

K191192SurgTech GENOLL Total Knee System K173455SurgTech Bipolar Head System K162125MALUC™ Total Hip Arthroplasty System K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation System K161894SurgTech Trauma System

Dispositivos Relacionados (Código: MAX)

K261049SCALA® TLSpineart SA K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SystemSeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Fonte oficial

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