FDA 510(k)

Système de trousse de colon vertébrale antérieure (STS) pour fusion endovertébrale

Numéro K : K170851 · 2017-08-07

Date de décision2017-08-07

Code produitMAX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Anterior Spine Truss System (STS) Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is 4Web, Inc.. It received FDA 510(k) clearance on 2017-08-07 under 510(k) number K170851. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Anterior Spine Truss System (STS) Interbody Fusion Device?

Anterior Spine Truss System (STS) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2017-08-07. The listed applicant is 4Web, Inc.. The 510(k) number is K170851.

When did Anterior Spine Truss System (STS) Interbody Fusion Device receive FDA 510(k) clearance?

Anterior Spine Truss System (STS) Interbody Fusion Device received FDA 510(k) clearance on 2017-08-07, under 510(k) number K170851.

Who is the listed applicant for Anterior Spine Truss System (STS) Interbody Fusion Device?

The FDA 510(k) record lists 4Web, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anterior Spine Truss System (STS) Interbody Fusion Device?

The FDA product code for Anterior Spine Truss System (STS) Interbody Fusion Device is MAX.

Essais cliniques associés

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Autres dossiers indiquant 4Web, Inc. en tant que demandeur

K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)K200002Système de Truss de la colonne vertébrale antérieure – Indépendant (ASTS-SA) pour l'anastomose intervertébrale K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)K190926Hammertoe Truss System (HTS)K172294Osteotomy Truss System (OTS)

Voir tous les 11 dispositifs →

Dispositifs connexes (Code : 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 SySeaSpine Orthopedics Corporation K253151Système de Cage de Fusion Intervertébral FuleBeijing Fule Science & Technology Development Co., Ltd.

Source officielle

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