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FDA 510(k)

MEGAFIX® Pedicle Screw Spinal System

K-Number: K191655 · 2020-03-06

ApplicantSeohancare Co., Ltd.
Decision Date2020-03-06
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEGAFIX® Pedicle Screw Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Seohancare Co., Ltd.. It received FDA 510(k) clearance on 2020-03-06 under 510(k) number K191655. 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 MEGAFIX® Pedicle Screw Spinal System?

MEGAFIX® Pedicle Screw Spinal System is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is Seohancare Co., Ltd.. The 510(k) number is K191655.

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

MEGAFIX® Pedicle Screw Spinal System received FDA 510(k) clearance on 2020-03-06, under 510(k) number K191655.

Who is the listed applicant for MEGAFIX® Pedicle Screw Spinal System?

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

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

The FDA product code for MEGAFIX® 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 PlacementRECRUITINGNCT07790068Evaluation of Safety of Complex Pedicle Screw Trajectories Using Patient-Specific Guides (MySpine, Medacta)ACTIVE_NOT_RECRUITING

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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