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FDA 510(k)

T-FIX® 3DSI Joint Fusion System

K-Number: K214123 · 2022-06-24

ApplicantCutting Edge Spine, LLC
Decision Date2022-06-24
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

T-FIX® 3DSI Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Cutting Edge Spine, LLC. It received FDA 510(k) clearance on 2022-06-24 under 510(k) number K214123. 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 T-FIX® 3DSI Joint Fusion System?

T-FIX® 3DSI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Cutting Edge Spine, LLC. The 510(k) number is K214123.

When did T-FIX® 3DSI Joint Fusion System receive FDA 510(k) clearance?

T-FIX® 3DSI Joint Fusion System received FDA 510(k) clearance on 2022-06-24, under 510(k) number K214123.

Who is the listed applicant for T-FIX® 3DSI Joint Fusion System?

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

What is the FDA product code for T-FIX® 3DSI Joint Fusion System?

The FDA product code for T-FIX® 3DSI Joint Fusion System is OUR.

Other records listing Cutting Edge 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.

K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemK230689T-FIX™ 3DSI Joint Fusion SystemK200991EVOL Spinal Interbody SystemK200552EVOS Lumbar Interbody SystemK192497EVOL ha - D Lateral Interbody Fusion SystemK190025EVOL® -SI Joint Fusion System

View all 9 devices →

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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