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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 a medical device manufactured by 4Web Medical, Inc.. It received FDA 510(k) clearance on 2024-11-01 under approval 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. It is manufactured by 4Web Medical, Inc.. The 510(k) number is K240388.

When was Osteotomy Truss System (OTS) approved by the FDA?

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

What company makes Osteotomy Truss System (OTS)?

Osteotomy Truss System (OTS) is manufactured by 4Web Medical, Inc..

What is the FDA product code for Osteotomy Truss System (OTS)?

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

Related Clinical Trials

NCT05966519 ROSA Knee Intraoperative Planning Flexibility Study RECRUITING

Other Devices by 4Web Medical, Inc.

K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device K221283Hammertoe Truss System (HTS) K220463Osteotomy Truss System (OTS) K212527Cervical Spine Truss System Plating Solution (CSTS-PS) K231739Cervical Spine Truss System (CSTS) K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device

View all 11 devices →

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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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