FDA.report

510(k) K232149

Device
BowTie? SI Joint Fusion System
Applicant
Sail Fusion, LLC
510(k) number
K232149
Product code
OUR
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-20
Date received
2023-07-19
Regulation
888.3040
Classification name
Sacroiliac Joint Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Benjamin Arnold
Address
2010 Jimmy Durante Blvd., Suite 200 Del Mar CA US 92014 92014

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00850053568572BowTie SI Fusion SystemSAIL FUSION, LLC2025-01-31
00850053568589BowTie SI Fusion SystemSAIL FUSION, LLC2025-01-27
00850053568114BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568008BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568015BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568022BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568039BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568046BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568053BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568060BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568077BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568084BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568091BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568107BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568251BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568121BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568138BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568145BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568152BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568169BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568176BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568183BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568190BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568206BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568213BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568220BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568237BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24
00850053568244BowTie SI Fusion SystemSAIL FUSION, LLC2024-05-24

Other 510(k) Records For Product Code OUR

510(k)DeviceApplicantDecision date
K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical2026-04-08
K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.2026-02-11
K253611Falco Fusion SystemMcnicoll Surgical, Inc.2026-01-29
K252834Sacroiliac Joint Truss System (SJTS)4Web Medical2026-01-28
K251365OptumSI Implant SystemSi Solutions, LLC2025-11-20
K252322SIros-X SystemGenesys Spine2025-10-22
K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.2025-10-09
K250894Eminent Spine Posterior SI SystemEminent Spine2025-10-07
K250647SImmetry+ SystemSivantage2025-07-29
K250247panaSIa SI Fusion SystemWenzel Spine, Inc.2025-07-09
K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.2025-06-26
K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC2025-06-06
K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC2025-06-06
K250001Patriot SI Implant SystemSpinal Simplicity, LLC2025-06-03
K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC2025-04-25