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FDA 510(k)

Mont Blanc and Mont Blanc MIS Spinal Systems

K-Number: K161387 · 2016-08-04

ApplicantSpineway SA
Decision Date2016-08-04
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mont Blanc and Mont Blanc MIS Spinal Systems is the device name listed in this FDA 510(k) record. The listed applicant is Spineway SA. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K161387. 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 and Mont Blanc MIS Spinal Systems?

Mont Blanc and Mont Blanc MIS Spinal Systems is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Spineway SA. The 510(k) number is K161387.

When did Mont Blanc and Mont Blanc MIS Spinal Systems receive FDA 510(k) clearance?

Mont Blanc and Mont Blanc MIS Spinal Systems received FDA 510(k) clearance on 2016-08-04, under 510(k) number K161387.

Who is the listed applicant for Mont Blanc and Mont Blanc MIS Spinal Systems?

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

What is the FDA product code for Mont Blanc and Mont Blanc MIS Spinal Systems?

The FDA product code for Mont Blanc and Mont Blanc MIS Spinal Systems is NKB.

Other records listing Spineway SA 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.

K231658VEOS Spinal Fixation SystemK191726mont blanc & mont blanc MIS Spinal SystemsK162694Ayers Rock Cervical interbody fusion 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

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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