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FDA 510(k)

Osteotomy Truss System (OTS)

K-Number: K240388 · 2024-11-01

Applicant4Web Medical, Inc.
Decision Date2024-11-01
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Osteotomy Truss System (OTS) 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 2024-11-01 under 510(k) number K240388. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Osteotomy Truss System (OTS)?

Osteotomy Truss System (OTS) is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is 4Web Medical, Inc.. The 510(k) number is K240388.

When did Osteotomy Truss System (OTS) receive FDA 510(k) clearance?

Osteotomy Truss System (OTS) received FDA 510(k) clearance on 2024-11-01, under 510(k) number K240388.

Who is the listed applicant for Osteotomy Truss System (OTS)?

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 Osteotomy Truss System (OTS)?

The FDA product code for Osteotomy Truss System (OTS) is HRS.

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)K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)K230088Ankle Truss System (ATS)K231739Cervical Spine Truss System (CSTS)

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Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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