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FDA 510(k)

ChanPin Pedicle Screw Spinal System

K-Number: K251251 · 2026-06-09

ApplicantChanpin Medtak Co., Ltd.
Decision Date2026-06-09
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ChanPin Pedicle Screw Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Chanpin Medtak Co., Ltd.. It received FDA 510(k) clearance on 2026-06-09 under 510(k) number K251251. 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 ChanPin Pedicle Screw Spinal System?

ChanPin Pedicle Screw Spinal System is a medical device that received FDA 510(k) clearance on 2026-06-09. The listed applicant is Chanpin Medtak Co., Ltd.. The 510(k) number is K251251.

When did ChanPin Pedicle Screw Spinal System receive FDA 510(k) clearance?

ChanPin Pedicle Screw Spinal System received FDA 510(k) clearance on 2026-06-09, under 510(k) number K251251.

Who is the listed applicant for ChanPin Pedicle Screw Spinal System?

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

What is the FDA product code for ChanPin Pedicle Screw Spinal System?

The FDA product code for ChanPin Pedicle Screw Spinal System 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.

NCT06960018Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw PlacementRECRUITING

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.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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