FDA 510(k)

Lateral Spine Truss System (LSTS) Interbody Fusion Device

K-Nummer: K211388 · 2021-08-05

Entscheidungsdatum2021-08-05

ProduktcodeMAX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Lateral Spine Truss System (LSTS) Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is 4Web Medical, Inc.. It received FDA 510(k) clearance on 2021-08-05 under 510(k) number K211388. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Lateral Spine Truss System (LSTS) Interbody Fusion Device?

Lateral Spine Truss System (LSTS) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is 4Web Medical, Inc.. The 510(k) number is K211388.

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

Lateral Spine Truss System (LSTS) Interbody Fusion Device received FDA 510(k) clearance on 2021-08-05, under 510(k) number K211388.

Who is the listed applicant for Lateral Spine Truss System (LSTS) Interbody Fusion Device?

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

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

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

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Weitere Einträge mit 4Web Medical, Inc. als Antragsteller

K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)K240388Osteotomy Truss System (OTS)K233966Vorderer Wirbelsäulen-Truss-System-Stand Alone (ASTS-SA)K230088Knöchel-Tragssystem (ATS)K231739Cervical Spine Truss System (CSTS)K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device

Alle 11 Geräte anzeigen →

Verwandte Geräte (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 SystemSeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Offizielle Quelle

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