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FDA 510(k)

BowTie™ SI Joint Fusion System

K-Number: K232149 · 2024-04-20

ApplicantSail Fusion, LLC
Decision Date2024-04-20
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BowTie™ SI Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Sail Fusion, LLC. It received FDA 510(k) clearance on 2024-04-20 under 510(k) number K232149. 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 BowTie™ SI Joint Fusion System?

BowTie™ SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2024-04-20. The listed applicant is Sail Fusion, LLC. The 510(k) number is K232149.

When did BowTie™ SI Joint Fusion System receive FDA 510(k) clearance?

BowTie™ SI Joint Fusion System received FDA 510(k) clearance on 2024-04-20, under 510(k) number K232149.

Who is the listed applicant for BowTie™ SI Joint Fusion System?

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

What is the FDA product code for BowTie™ SI Joint Fusion System?

The FDA product code for BowTie™ SI Joint Fusion System 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 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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