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FDA 510(k)

Anterior Spine Truss System-Stand Alone (ASTS-SA)

K-Number: K233966 · 2024-04-22

Applicant4Web Medical, Inc.
Decision Date2024-04-22
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Anterior Spine Truss System-Stand Alone (ASTS-SA) 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 2024-04-22 under 510(k) number K233966. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anterior Spine Truss System-Stand Alone (ASTS-SA)?

Anterior Spine Truss System-Stand Alone (ASTS-SA) is a medical device that received FDA 510(k) clearance on 2024-04-22. The listed applicant is 4Web Medical, Inc.. The 510(k) number is K233966.

When did Anterior Spine Truss System-Stand Alone (ASTS-SA) receive FDA 510(k) clearance?

Anterior Spine Truss System-Stand Alone (ASTS-SA) received FDA 510(k) clearance on 2024-04-22, under 510(k) number K233966.

Who is the listed applicant for Anterior Spine Truss System-Stand Alone (ASTS-SA)?

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 Anterior Spine Truss System-Stand Alone (ASTS-SA)?

The FDA product code for Anterior Spine Truss System-Stand Alone (ASTS-SA) is OVD.

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Other records listing 4Web Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252834Sacroiliac Joint Truss System (SJTS)K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)K251117Cervical Spine Truss System (CSTS)K240388Osteotomy Truss System (OTS)K230088Ankle Truss System (ATS)K231739Cervical Spine Truss System (CSTS)

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Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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