FDA 510(k)

Renovis S141 Lumbar Interbody Fusion System

Número K: K170888 · 2017-08-08

Data da decisão2017-08-08

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Renovis S141 Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Renovis Surgical Technologies. It received FDA 510(k) clearance on 2017-08-08 under 510(k) number K170888. 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 Renovis S141 Lumbar Interbody Fusion System?

Renovis S141 Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2017-08-08. The listed applicant is Renovis Surgical Technologies. The 510(k) number is K170888.

When did Renovis S141 Lumbar Interbody Fusion System receive FDA 510(k) clearance?

Renovis S141 Lumbar Interbody Fusion System received FDA 510(k) clearance on 2017-08-08, under 510(k) number K170888.

Who is the listed applicant for Renovis S141 Lumbar Interbody Fusion System?

The FDA 510(k) record lists Renovis Surgical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Renovis S141 Lumbar Interbody Fusion System?

The FDA product code for Renovis S141 Lumbar Interbody Fusion System is MAX.

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Outros registros que listam Renovis Surgical Technologies como candidato(a)

K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee System K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System K181655Renovis S180 Lateral Lumbar Interbody Fusion System K171543Renovis Surgical Hip Replacement System K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) 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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