Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Osteotomy Truss System (OTS)

K-Number: K220463 · 2022-05-18

Applicant4Web Medical, Inc.
Decision Date2022-05-18
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 2022-05-18 under approval number K220463. 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 2022-05-18. It is manufactured by 4Web Medical, Inc.. The 510(k) number is K220463.

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

Osteotomy Truss System (OTS) received FDA 510(k) clearance on 2022-05-18, under approval number K220463.

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) K212527Cervical Spine Truss System Plating Solution (CSTS-PS) K231739Cervical Spine Truss System (CSTS) K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device

View all 11 devices →

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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.

↑