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FDA 510(k)

Triton™ Sacroiliac Joint Fixation System

K-Number: K211449 · 2021-08-31

ApplicantChoice Spine, LLC
Decision Date2021-08-31
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Triton™ Sacroiliac Joint Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Choice Spine, LLC. It received FDA 510(k) clearance on 2021-08-31 under 510(k) 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. The listed applicant is Choice Spine, LLC. The 510(k) number is K211449.

When did Triton™ Sacroiliac Joint Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Triton™ Sacroiliac Joint Fixation System?

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

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

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

Related Clinical Trials

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.

NCT05367505Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the PelvisACTIVE_NOT_RECRUITING

Other records listing Choice Spine, 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.

K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemK220953ChoiceSpine TigerShark™ M, Modular Interbody SystemK220024ChoiceSpine Navigation SystemK203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemK203561ChoiceSpine Navigation SystemK201643ChoiceSpine Tiger Shark Cervical Spacer System

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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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