FDA 510(k)

SiJoin®T3

K-Number: K213815 · 2023-03-29

Decision Date2023-03-29

Product CodeOUR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SiJoin®T3 is the device name listed in this FDA 510(k) record. The listed applicant is Vgi Medical, Inc.. It received FDA 510(k) clearance on 2023-03-29 under 510(k) number K213815. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SiJoin®T3?

SiJoin®T3 is a medical device that received FDA 510(k) clearance on 2023-03-29. The listed applicant is Vgi Medical, Inc.. The 510(k) number is K213815.

When did SiJoin®T3 receive FDA 510(k) clearance?

SiJoin®T3 received FDA 510(k) clearance on 2023-03-29, under 510(k) number K213815.

Who is the listed applicant for SiJoin®T3?

The FDA 510(k) record lists Vgi Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SiJoin®T3?

The FDA product code for SiJoin®T3 is OUR.

Related Devices (Code: OUR)

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.

K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web Medical K251365OptumSI Implant SystemSi Solutions, LLC K252322SIros-X SystemGenesys Spine

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.