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FDA 510(k)

TiLink-L SI Joint Fusion System

K-Number: K230446 · 2023-06-07

ApplicantSurGenTec, LLC
Decision Date2023-06-07
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TiLink-L SI Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2023-06-07 under 510(k) number K230446. 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 TiLink-L SI Joint Fusion System?

TiLink-L SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2023-06-07. The listed applicant is SurGenTec, LLC. The 510(k) number is K230446.

When did TiLink-L SI Joint Fusion System receive FDA 510(k) clearance?

TiLink-L SI Joint Fusion System received FDA 510(k) clearance on 2023-06-07, under 510(k) number K230446.

Who is the listed applicant for TiLink-L SI Joint Fusion System?

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

What is the FDA product code for TiLink-L SI Joint Fusion System?

The FDA product code for TiLink-L SI Joint Fusion System is OUR.

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Other records listing SurGenTec, LLC 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.

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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 MedicalK253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalK251365OptumSI Implant SystemSi Solutions, LLCK252322SIros-X SystemGenesys Spine

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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