ARx® SAI Implant System— 510(k) K254274
Substantially EquivalentLife Spine, Inc.
FDA 510(k) clearance K254274 for ARx® SAI Implant System, Substantially Equivalent on 2026-04-16. Applicant: Life Spine, Inc.. Device class: 2.
Summary
Life Spine's ARx SAI Implant System is filed under product code NKB (Thoracolumbosacral Pedicle Screw System). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3070. It came in as a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.
Life Spine filed from Huntley, Illinois. Review took 107 calendar days (December 30, 2025 to April 16, 2026).
Clearance details
- Applicant
- Life Spine, Inc.
- Product code
- Product code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huntley, IL, US
Recent devices under product code NKB
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- K260571 — SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
- K260837 — VersaLift Expandable System
- K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System
- K251502 — TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
Adverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.