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FDA 510(k)

GPS, G SURGICAL PEDICLE SYSTEM

K-Number: K081041 · 2008-06-27

ApplicantG Surgical Co., Ltd.
Decision Date2008-06-27
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GPS, G SURGICAL PEDICLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is G Surgical Co., Ltd.. It received FDA 510(k) clearance on 2008-06-27 under 510(k) number K081041. 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 GPS, G SURGICAL PEDICLE SYSTEM?

GPS, G SURGICAL PEDICLE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-27. The listed applicant is G Surgical Co., Ltd.. The 510(k) number is K081041.

When did GPS, G SURGICAL PEDICLE SYSTEM receive FDA 510(k) clearance?

GPS, G SURGICAL PEDICLE SYSTEM received FDA 510(k) clearance on 2008-06-27, under 510(k) number K081041.

Who is the listed applicant for GPS, G SURGICAL PEDICLE SYSTEM?

The FDA 510(k) record lists G Surgical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GPS, G SURGICAL PEDICLE SYSTEM?

The FDA product code for GPS, G SURGICAL PEDICLE SYSTEM is MNH. This falls under the ENT category.

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 G Surgical Co., Ltd. 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.

K103070GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +

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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