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FDA 510(k)

INTRAMEDULLARY NAIL SYSTEM

K-Number: K122994 · 2013-04-12

ApplicantWeigao Orthopaedic Device Co., Ltd.
Decision Date2013-04-12
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTRAMEDULLARY NAIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Weigao Orthopaedic Device Co., Ltd.. It received FDA 510(k) clearance on 2013-04-12 under 510(k) number K122994. 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 INTRAMEDULLARY NAIL SYSTEM?

INTRAMEDULLARY NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-12. The listed applicant is Weigao Orthopaedic Device Co., Ltd.. The 510(k) number is K122994.

When did INTRAMEDULLARY NAIL SYSTEM receive FDA 510(k) clearance?

INTRAMEDULLARY NAIL SYSTEM received FDA 510(k) clearance on 2013-04-12, under 510(k) number K122994.

Who is the listed applicant for INTRAMEDULLARY NAIL SYSTEM?

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

What is the FDA product code for INTRAMEDULLARY NAIL SYSTEM?

The FDA product code for INTRAMEDULLARY NAIL SYSTEM is MNH. This falls under the ENT category.

Related Clinical Trials

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Other records listing Weigao Orthopaedic Device 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.

K130340LOCKING BONE PLATES AND SCREWSK123578ANTERIOR CERVICAL PLATE SYSTEMK121312INTRAMEDULLARY NAIL 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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