FDA 510(k)

Triton Sacroiliac Joint Fixation System

K-Number: K211449 · 2021-08-31

Decision Date2021-08-31

Product CodeOUR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Triton Sacroiliac Joint Fixation System is a medical device manufactured by Choice Spine, LLC. It received FDA 510(k) clearance on 2021-08-31 under approval number K211449. 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 Triton Sacroiliac Joint Fixation System?

Triton Sacroiliac Joint Fixation System is a medical device that received FDA 510(k) clearance on 2021-08-31. It is manufactured by Choice Spine, LLC. The 510(k) number is K211449.

When was Triton Sacroiliac Joint Fixation System approved by the FDA?

Triton Sacroiliac Joint Fixation System received FDA 510(k) clearance on 2021-08-31, under approval number K211449.

What company makes Triton Sacroiliac Joint Fixation System?

Triton Sacroiliac Joint Fixation System is manufactured by Choice Spine, LLC.

What is the FDA product code for Triton Sacroiliac Joint Fixation System?

The FDA product code for Triton Sacroiliac Joint Fixation System is OUR.

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Other Devices by Choice Spine, LLC

K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System K191367Harrier-SA Lumbar Interbody System K201643ChoiceSpine Tiger Shark Cervical Spacer System K203311ChoiceSpine Blackhawk Ti Cervical Spacer System K203561ChoiceSpine Navigation System K220953ChoiceSpine TigerShark M, Modular Interbody System

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Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

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.