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FDA 510(k)

INTRAMEDULLARY NAIL SYSTEM

K-Number: K121312 · 2012-10-24

ApplicantWeigao Orthopaedic Device Co., Ltd.
Decision Date2012-10-24
Product CodeHSB
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 2012-10-24 under 510(k) number K121312. The device is classified under product code HSB. It was reviewed by the OR advisory panel. 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 2012-10-24. The listed applicant is Weigao Orthopaedic Device Co., Ltd.. The 510(k) number is K121312.

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

INTRAMEDULLARY NAIL SYSTEM received FDA 510(k) clearance on 2012-10-24, under 510(k) number K121312.

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 HSB.

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.

K122994INTRAMEDULLARY NAIL SYSTEMK130340LOCKING BONE PLATES AND SCREWSK123578ANTERIOR CERVICAL PLATE SYSTEM

Related Devices (Code: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices 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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