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FDA 510(k)

KHEIRON® Spinal Fixation System, including patient specific K-ROD

K-Number: K251804 · 2025-07-08

ApplicantS.M.A.I.O
Decision Date2025-07-08
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KHEIRON® Spinal Fixation System, including patient specific K-ROD is the device name listed in this FDA 510(k) record. The listed applicant is S.M.A.I.O. It received FDA 510(k) clearance on 2025-07-08 under 510(k) number K251804. 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 KHEIRON® Spinal Fixation System, including patient specific K-ROD?

KHEIRON® Spinal Fixation System, including patient specific K-ROD is a medical device that received FDA 510(k) clearance on 2025-07-08. The listed applicant is S.M.A.I.O. The 510(k) number is K251804.

When did KHEIRON® Spinal Fixation System, including patient specific K-ROD receive FDA 510(k) clearance?

KHEIRON® Spinal Fixation System, including patient specific K-ROD received FDA 510(k) clearance on 2025-07-08, under 510(k) number K251804.

Who is the listed applicant for KHEIRON® Spinal Fixation System, including patient specific K-ROD?

The FDA 510(k) record lists S.M.A.I.O as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KHEIRON® Spinal Fixation System, including patient specific K-ROD?

The FDA product code for KHEIRON® Spinal Fixation System, including patient specific K-ROD is NKB.

Related Clinical Trials

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.

NCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITING

Other records listing S.M.A.I.O as applicant

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.

K253802KHEIRON® Spinal Fixation System, including patient specific K-RODK260786KHEIRON® Spinal Fixation System, including patient specific K-RODK253990KHEIRON® Spinal Fixation System, including patient specific K-RODK253721KHEIRON® Spinal Fixation System, including patient specific K-RODK232650KHEIRON® Spinal Fixation System, including patient specific K-RODK223841KBA3D

View all 11 devices →

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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