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FDA 510(k)

MONDEAL CONTOUR HO SYSTEM

K-Number: K050657 · 2005-08-08

ApplicantKapp Surgical Instrument, Inc.
Decision Date2005-08-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONDEAL CONTOUR HO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kapp Surgical Instrument, Inc.. It received FDA 510(k) clearance on 2005-08-08 under 510(k) number K050657. 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 MONDEAL CONTOUR HO SYSTEM?

MONDEAL CONTOUR HO SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-08. The listed applicant is Kapp Surgical Instrument, Inc.. The 510(k) number is K050657.

When did MONDEAL CONTOUR HO SYSTEM receive FDA 510(k) clearance?

MONDEAL CONTOUR HO SYSTEM received FDA 510(k) clearance on 2005-08-08, under 510(k) number K050657.

Who is the listed applicant for MONDEAL CONTOUR HO SYSTEM?

The FDA 510(k) record lists Kapp Surgical Instrument, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONDEAL CONTOUR HO SYSTEM?

The FDA product code for MONDEAL CONTOUR HO SYSTEM is HRS.

Related Clinical Trials

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Other records listing Kapp Surgical Instrument, Inc. 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.

K200289Michler-Kapp Cardiovascular Vent CatheterK072216KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536K050384KAPP BARI-RING, MODEL KS-BR-2005K050655MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005K033930KAPP CUSTOM ULNAR HEAD WRIST IMPLANTK030237KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT

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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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