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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 a medical device manufactured by Allumin8, Inc.. It received FDA 510(k) clearance on 2025-10-20 under approval 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. It is manufactured by Allumin8, Inc.. The 510(k) number is K242827.

When was A8 INTEGR8™ Porous Pedicle Screws approved by the FDA?

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

What company makes A8 INTEGR8™ Porous Pedicle Screws?

A8 INTEGR8™ Porous Pedicle Screws is manufactured by Allumin8, Inc..

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 Clinical Trials

NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT07408726 Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization NOT_YET_RECRUITING

Related Devices (Code: NKB)

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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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