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FDA 510(k)

LOCKING BONE PLATES AND SCREWS

K-Number: K130340 · 2013-04-05

ApplicantWeigao Orthopaedic Device Co., Ltd.
Decision Date2013-04-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOCKING BONE PLATES AND SCREWS 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 2013-04-05 under 510(k) number K130340. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOCKING BONE PLATES AND SCREWS?

LOCKING BONE PLATES AND SCREWS is a medical device that received FDA 510(k) clearance on 2013-04-05. The listed applicant is Weigao Orthopaedic Device Co., Ltd.. The 510(k) number is K130340.

When did LOCKING BONE PLATES AND SCREWS receive FDA 510(k) clearance?

LOCKING BONE PLATES AND SCREWS received FDA 510(k) clearance on 2013-04-05, under 510(k) number K130340.

Who is the listed applicant for LOCKING BONE PLATES AND SCREWS?

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 LOCKING BONE PLATES AND SCREWS?

The FDA product code for LOCKING BONE PLATES AND SCREWS is HRS.

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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 SYSTEMK123578ANTERIOR CERVICAL PLATE SYSTEMK121312INTRAMEDULLARY NAIL SYSTEM

Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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