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FDA 510(k)

MONT BLANC PEDICLE SCREW SYSTEMS

K-Number: K112684 · 2012-05-01

ApplicantQualgenix
Decision Date2012-05-01
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONT BLANC PEDICLE SCREW SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Qualgenix. It received FDA 510(k) clearance on 2012-05-01 under 510(k) number K112684. 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 MONT BLANC PEDICLE SCREW SYSTEMS?

MONT BLANC PEDICLE SCREW SYSTEMS is a medical device that received FDA 510(k) clearance on 2012-05-01. The listed applicant is Qualgenix. The 510(k) number is K112684.

When did MONT BLANC PEDICLE SCREW SYSTEMS receive FDA 510(k) clearance?

MONT BLANC PEDICLE SCREW SYSTEMS received FDA 510(k) clearance on 2012-05-01, under 510(k) number K112684.

Who is the listed applicant for MONT BLANC PEDICLE SCREW SYSTEMS?

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

What is the FDA product code for MONT BLANC PEDICLE SCREW SYSTEMS?

The FDA product code for MONT BLANC PEDICLE SCREW SYSTEMS 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.

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Other records listing Qualgenix 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.

K112801AYERS ROCK CERVICAL CAGE

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ 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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