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FDA 510(k)

GALLEON PEDICLE SCREW SYSTEM

K-Number: K122814 · 2012-12-03

ApplicantEverest Spine, LLC
Decision Date2012-12-03
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GALLEON PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Everest Spine, LLC. It received FDA 510(k) clearance on 2012-12-03 under 510(k) number K122814. 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 GALLEON PEDICLE SCREW SYSTEM?

GALLEON PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-03. The listed applicant is Everest Spine, LLC. The 510(k) number is K122814.

When did GALLEON PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

GALLEON PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2012-12-03, under 510(k) number K122814.

Who is the listed applicant for GALLEON PEDICLE SCREW SYSTEM?

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

What is the FDA product code for GALLEON PEDICLE SCREW SYSTEM?

The FDA product code for GALLEON PEDICLE SCREW SYSTEM is MNH. This falls under the ENT category.

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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

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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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