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FDA 510(k)

Nano FortiFix® System

K-Number: K193211 · 2020-03-20

ApplicantNanovis Spine, LLC
Decision Date2020-03-20
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Nano FortiFix® System is the device name listed in this FDA 510(k) record. The listed applicant is Nanovis Spine, LLC. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K193211. 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 Nano FortiFix® System?

Nano FortiFix® System is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Nanovis Spine, LLC. The 510(k) number is K193211.

When did Nano FortiFix® System receive FDA 510(k) clearance?

Nano FortiFix® System received FDA 510(k) clearance on 2020-03-20, under 510(k) number K193211.

Who is the listed applicant for Nano FortiFix® System?

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

What is the FDA product code for Nano FortiFix® System?

The FDA product code for Nano FortiFix® System is NKB.

Other records listing Nanovis Spine, LLC 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.

K162250FortiBridge Anterior Cervical Plate System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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