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FDA 510(k)

ARx® SAI Implant System

K-Number: K254274 · 2026-04-16

ApplicantLife Spine, Inc.
Decision Date2026-04-16
Product CodeNKB
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 2026-04-16 under approval number K254274. The device is classified under product code NKB. 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 2026-04-16. It is manufactured by Life Spine, Inc.. The 510(k) number is K254274.

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

ARx® SAI Implant System received FDA 510(k) clearance on 2026-04-16, under approval number K254274.

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 NKB.

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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: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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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