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FDA 510(k)

Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System

K-Number: K261284 · 2026-07-14

ApplicantAlphatec Spine, Inc.
Decision Date2026-07-14
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2026-07-14 under 510(k) number K261284. 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 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System?

Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K261284.

When did Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System receive FDA 510(k) clearance?

Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System received FDA 510(k) clearance on 2026-07-14, under 510(k) number K261284.

Who is the listed applicant for Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System?

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

What is the FDA product code for Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System?

The FDA product code for Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System is NKB.

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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.

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.K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ SystemGlobus Medical, Inc.K261130AccelFix Spinal Fixation SystemL&K BIOMED 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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