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510(k) K242827

A8 INTEGR8™ Porous Pedicle Screws by Allumin8, Inc. — Product Code NKB

K242827 is an FDA 510(k) premarket notification submitted by Allumin8, Inc. for the device "A8 INTEGR8™ Porous Pedicle Screws". The FDA issued a decision of Substantially Equivalent on Oct 20, 2025. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 20, 2025
Date Received
Sep 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (Jul 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (Jul 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (Jun 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (Jun 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)

FDA data resources