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FDA 510(k)

Osteotomy Truss System (OTS)

K-Number: K172294 · 2018-02-22

Applicant4Web, Inc.
Decision Date2018-02-22
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, Inc.. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K172294. 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 2018-02-22. The listed applicant is 4Web, Inc.. The 510(k) number is K172294.

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

Osteotomy Truss System (OTS) received FDA 510(k) clearance on 2018-02-22, under 510(k) number K172294.

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

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 Osteotomy Truss System (OTS)?

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

Other records listing 4Web, 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.

K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)K200002Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion DeviceK190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)K190926Hammertoe Truss System (HTS)K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device

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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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