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FDA 510(k)

ARx® SAI Implant System

K-Number: K241464 · 2024-07-29

ApplicantLife Spine, Inc.
Decision Date2024-07-29
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARx® SAI Implant System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2024-07-29 under approval number K241464. 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 ARx® SAI Implant System?

ARx® SAI Implant System is a medical device that received FDA 510(k) clearance on 2024-07-29. It is manufactured by Life Spine, Inc.. The 510(k) number is K241464.

When was ARx® SAI Implant System approved by the FDA?

ARx® SAI Implant System received FDA 510(k) clearance on 2024-07-29, under approval number K241464.

What company makes ARx® SAI Implant System?

ARx® SAI Implant System is manufactured by Life Spine, Inc..

What is the FDA product code for ARx® SAI Implant System?

The FDA product code for ARx® SAI Implant System is OUR.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Life Spine, Inc.

K161127The Small PLATEAU (PLATEAU-C) Spacer System K160066Pro-Link® Stand-Alone Cervical Spacer System K161037Tarsa-Link Stand-Alone Wedge Fixation System K153065The Hammertoe Correction System K153400ProLift Expandable System K172973Life Spine Foot and Ankle Plating 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.

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