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FDA 510(k)

MONARCH SPINE SYSTEM

K-Number: K010576 · 2001-05-23

ApplicantDepuyacromed
Decision Date2001-05-23
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONARCH SPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuyacromed. It received FDA 510(k) clearance on 2001-05-23 under 510(k) number K010576. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONARCH SPINE SYSTEM?

MONARCH SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2001-05-23. The listed applicant is Depuyacromed. The 510(k) number is K010576.

When did MONARCH SPINE SYSTEM receive FDA 510(k) clearance?

MONARCH SPINE SYSTEM received FDA 510(k) clearance on 2001-05-23, under 510(k) number K010576.

Who is the listed applicant for MONARCH SPINE SYSTEM?

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

What is the FDA product code for MONARCH SPINE SYSTEM?

The FDA product code for MONARCH SPINE SYSTEM is MNI.

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Other records listing Depuyacromed 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.

K040197EAGLE ANTERIOR CERVIAL PLATE SYSTEMK031635DEPUY ACROMED VBR SYSTEMK030833DEPUY ACROMED VBR SYSTEMK030383MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWSK030249SURGICAL TITANIUM MESH SYSTEMK030103SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS

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Related Devices (Code: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device 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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