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FDA 510(k)

IRIX-A Lumbar Integrated Fusion System

K-Number: K171567 · 2017-08-28

ApplicantX-Spine Systems, Inc.
Decision Date2017-08-28
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IRIX-A Lumbar Integrated Fusion System is a medical device manufactured by X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2017-08-28 under approval number K171567. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRIX-A Lumbar Integrated Fusion System?

IRIX-A Lumbar Integrated Fusion System is a medical device that received FDA 510(k) clearance on 2017-08-28. It is manufactured by X-Spine Systems, Inc.. The 510(k) number is K171567.

When was IRIX-A Lumbar Integrated Fusion System approved by the FDA?

IRIX-A Lumbar Integrated Fusion System received FDA 510(k) clearance on 2017-08-28, under approval number K171567.

What company makes IRIX-A Lumbar Integrated Fusion System?

IRIX-A Lumbar Integrated Fusion System is manufactured by X-Spine Systems, Inc..

What is the FDA product code for IRIX-A Lumbar Integrated Fusion System?

The FDA product code for IRIX-A Lumbar Integrated Fusion System is OVD.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED

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: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (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)

Other Devices by X-Spine Systems, Inc.

K160959Xsert Lumbar Expandable Interbody System K162944Irix-C Cervical Integrated Fusion System K160428Certex Spinal Fixation System K160114Xspan Laminoplasty Fixation System K170119Calix Lumbar Spinal Implant System K171075Calix-C Cervical Interbody Spacer

View all 11 devices →

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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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