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FDA 510(k)

“Socko” Vimax Spinal Fixation System

K-Number: K253045 · 2026-06-17

ApplicantSocko Medical Co., Ltd.
Decision Date2026-06-17
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

“Socko” Vimax Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Socko Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K253045. 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 “Socko” Vimax Spinal Fixation System?

“Socko” Vimax Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Socko Medical Co., Ltd.. The 510(k) number is K253045.

When did “Socko” Vimax Spinal Fixation System receive FDA 510(k) clearance?

“Socko” Vimax Spinal Fixation System received FDA 510(k) clearance on 2026-06-17, under 510(k) number K253045.

Who is the listed applicant for “Socko” Vimax Spinal Fixation System?

The FDA 510(k) record lists Socko Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for “Socko” Vimax Spinal Fixation System?

The FDA product code for “Socko” Vimax Spinal Fixation System 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.OK251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)

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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