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FDA 510(k)

MICROWARE BONE PLATES AND BONE SCREW

K-Number: K111008 · 2012-05-02

ApplicantMicroware Precision Co., Ltd.
Decision Date2012-05-02
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICROWARE BONE PLATES AND BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Microware Precision Co., Ltd.. It received FDA 510(k) clearance on 2012-05-02 under 510(k) number K111008. 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 MICROWARE BONE PLATES AND BONE SCREW?

MICROWARE BONE PLATES AND BONE SCREW is a medical device that received FDA 510(k) clearance on 2012-05-02. The listed applicant is Microware Precision Co., Ltd.. The 510(k) number is K111008.

When did MICROWARE BONE PLATES AND BONE SCREW receive FDA 510(k) clearance?

MICROWARE BONE PLATES AND BONE SCREW received FDA 510(k) clearance on 2012-05-02, under 510(k) number K111008.

Who is the listed applicant for MICROWARE BONE PLATES AND BONE SCREW?

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

What is the FDA product code for MICROWARE BONE PLATES AND BONE SCREW?

The FDA product code for MICROWARE BONE PLATES AND BONE SCREW is HRS.

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Other records listing Microware Precision Co., Ltd. as applicant

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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

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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