FDA.report

510(k) K211449

Device
Triton? Sacroiliac Joint Fixation System
Applicant
Choice Spine, LLC
510(k) number
K211449
Product code
OUR
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-31
Date received
2021-05-10
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
Kim Finch
Address
400 Erin Dr. Knoxville TN US 37919 37919

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00840996184564TRITONChoice Spine, LP2023-07-06
00840996184489TRITONChoice Spine, LP2023-07-06
00840996184496TRITONChoice Spine, LP2023-07-06
00840996184526TRITONChoice Spine, LP2023-07-06
00840996184533TRITONChoice Spine, LP2023-07-06
00840996184540TRITONChoice Spine, LP2023-07-06
00840996184519TRITONChoice Spine, LP2023-07-06
00840996184465TRITONChoice Spine, LP2023-07-06
00840996184458TRITONChoice Spine, LP2023-07-06
00840996184441TRITONChoice Spine, LP2023-07-06
00840996184434TRITONChoice Spine, LP2023-07-06
00840996184427TRITONChoice Spine, LP2023-07-06
00840996184410TRITONChoice Spine, LP2023-07-06
00840996184403TRITONChoice Spine, LP2023-07-06
00840996184472TRITONChoice Spine, LP2023-07-06
00840996184557TRITONChoice Spine, LP2023-07-06
00840996184571TRITONChoice Spine, LP2023-07-06
00840996184588TRITONChoice Spine, LP2023-07-06
00840996184595TRITONChoice Spine, LP2023-07-06
00840996184601TRITONChoice Spine, LP2023-07-06
00840996184618TRITONChoice Spine, LP2023-07-06
00840996184625TRITONChoice Spine, LP2023-07-06
00840996184632TRITONChoice Spine, LP2023-07-06
00840996184649TRITONChoice Spine, LP2023-07-06
00840996184687TRITON SI FIXATIONChoice Spine, LP2023-07-06
00840996184694TRITON SI FIXATIONChoice Spine, LP2023-07-06
00840996184700TRITON SI FIXATIONChoice Spine, LP2023-07-06
00840996184717TRITON SI FIXATIONChoice Spine, LP2023-07-06
00840996184724TRITON SI FIXATIONChoice Spine, LP2023-07-06
00840996186438TRITONChoice Spine, LP2023-07-06

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K251365OptumSI Implant SystemSi Solutions, LLC2025-11-20
K252322SIros-X SystemGenesys Spine2025-10-22
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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