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FDA 510(k)

MIOT PLATING SYSTEM

K-Number: K051945 · 2005-09-06

ApplicantOrthofix Srl
Decision Date2005-09-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MIOT PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2005-09-06 under 510(k) number K051945. 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 MIOT PLATING SYSTEM?

MIOT PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2005-09-06. The listed applicant is Orthofix Srl. The 510(k) number is K051945.

When did MIOT PLATING SYSTEM receive FDA 510(k) clearance?

MIOT PLATING SYSTEM received FDA 510(k) clearance on 2005-09-06, under 510(k) number K051945.

Who is the listed applicant for MIOT PLATING SYSTEM?

The FDA 510(k) record lists Orthofix Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIOT PLATING SYSTEM?

The FDA product code for MIOT PLATING SYSTEM is HRS.

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Other records listing Orthofix Srl 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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