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FDA 510(k)

Irix-C Cervical Integrated Fusion System

K-Number: K162944 · 2016-11-07

ApplicantX-Spine Systems, Inc.
Decision Date2016-11-07
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Irix-C Cervical Integrated Fusion System is a medical device manufactured by X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2016-11-07 under approval number K162944. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Irix-C Cervical Integrated Fusion System?

Irix-C Cervical Integrated Fusion System is a medical device that received FDA 510(k) clearance on 2016-11-07. It is manufactured by X-Spine Systems, Inc.. The 510(k) number is K162944.

When was Irix-C Cervical Integrated Fusion System approved by the FDA?

Irix-C Cervical Integrated Fusion System received FDA 510(k) clearance on 2016-11-07, under approval number K162944.

What company makes Irix-C Cervical Integrated Fusion System?

Irix-C Cervical Integrated Fusion System is manufactured by X-Spine Systems, Inc..

What is the FDA product code for Irix-C Cervical Integrated Fusion System?

The FDA product code for Irix-C Cervical Integrated Fusion System is OVE.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT07579832 Quantitative Monitoring of Disability Care Quality for Long-Term Care Facilities 2 NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by X-Spine Systems, Inc.

K160959Xsert Lumbar Expandable Interbody System K160428Certex Spinal Fixation System K160114Xspan Laminoplasty Fixation System K170119Calix Lumbar Spinal Implant System K171567IRIX-A Lumbar Integrated Fusion System K171075Calix-C Cervical Interbody Spacer

View all 11 devices →

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc. K153352Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody SystemSpinal Elements, Inc.

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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