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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 the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2026-04-16 under 510(k) 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. The listed applicant is Life Spine, Inc.. The 510(k) number is K254274.

When did ARx® SAI Implant System receive FDA 510(k) clearance?

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

Who is the listed applicant for ARx® SAI Implant System?

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

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

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

Other records listing Life Spine, Inc. as applicant

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Related Devices (Code: NKB)

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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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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