FDA 510(k)

Endoskeleton TO Interbody Fusion Device (IBD)

Número K: K170399 · 2017-07-06

Data da decisão2017-07-06

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Endoskeleton TO Interbody Fusion Device (IBD) is the device name listed in this FDA 510(k) record. The listed applicant is Titan Spine, LLC. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K170399. 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 Endoskeleton TO Interbody Fusion Device (IBD)?

Endoskeleton TO Interbody Fusion Device (IBD) is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Titan Spine, LLC. The 510(k) number is K170399.

When did Endoskeleton TO Interbody Fusion Device (IBD) receive FDA 510(k) clearance?

Endoskeleton TO Interbody Fusion Device (IBD) received FDA 510(k) clearance on 2017-07-06, under 510(k) number K170399.

Who is the listed applicant for Endoskeleton TO Interbody Fusion Device (IBD)?

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

What is the FDA product code for Endoskeleton TO Interbody Fusion Device (IBD)?

The FDA product code for Endoskeleton TO Interbody Fusion Device (IBD) is MAX.

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Outros registros que listam Titan Spine, LLC como candidato(a)

K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device K163269Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device

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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