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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 a medical device manufactured by 4Web, Inc.. It received FDA 510(k) clearance on 2018-02-22 under approval 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. It is manufactured by 4Web, Inc.. The 510(k) number is K172294.

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

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

What company makes Osteotomy Truss System (OTS)?

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

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View all 11 devices →

Related Devices (Code: HRS)

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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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