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FDA 510(k)

MONARCH SPINAL SYSTEMS

K-Number: K013294 · 2001-10-09

ApplicantDepuyacromed
Decision Date2001-10-09
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONARCH SPINAL SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Depuyacromed. It received FDA 510(k) clearance on 2001-10-09 under 510(k) number K013294. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONARCH SPINAL SYSTEMS?

MONARCH SPINAL SYSTEMS is a medical device that received FDA 510(k) clearance on 2001-10-09. The listed applicant is Depuyacromed. The 510(k) number is K013294.

When did MONARCH SPINAL SYSTEMS receive FDA 510(k) clearance?

MONARCH SPINAL SYSTEMS received FDA 510(k) clearance on 2001-10-09, under 510(k) number K013294.

Who is the listed applicant for MONARCH SPINAL SYSTEMS?

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 SPINAL SYSTEMS?

The FDA product code for MONARCH SPINAL SYSTEMS is MNH. This falls under the ENT category.

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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: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S 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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