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FDA 510(k)

A8 INTEGR8™ Porous Pedicle Screws

K-Number: K242827 · 2025-10-20

ApplicantAllumin8, Inc.
Decision Date2025-10-20
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

A8 INTEGR8™ Porous Pedicle Screws is the device name listed in this FDA 510(k) record. The listed applicant is Allumin8, Inc.. It received FDA 510(k) clearance on 2025-10-20 under 510(k) number K242827. 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 A8 INTEGR8™ Porous Pedicle Screws?

A8 INTEGR8™ Porous Pedicle Screws is a medical device that received FDA 510(k) clearance on 2025-10-20. The listed applicant is Allumin8, Inc.. The 510(k) number is K242827.

When did A8 INTEGR8™ Porous Pedicle Screws receive FDA 510(k) clearance?

A8 INTEGR8™ Porous Pedicle Screws received FDA 510(k) clearance on 2025-10-20, under 510(k) number K242827.

Who is the listed applicant for A8 INTEGR8™ Porous Pedicle Screws?

The FDA 510(k) record lists Allumin8, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A8 INTEGR8™ Porous Pedicle Screws?

The FDA product code for A8 INTEGR8™ Porous Pedicle Screws is NKB.

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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