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FDA 510(k)

MONDEAL HAND CONTOUR SYSTEM

K-Number: K071797 · 2007-09-17

ApplicantMondeal Medical Systems GmbH
Decision Date2007-09-17
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONDEAL HAND CONTOUR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mondeal Medical Systems GmbH. It received FDA 510(k) clearance on 2007-09-17 under 510(k) number K071797. 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 HAND CONTOUR SYSTEM?

MONDEAL HAND CONTOUR SYSTEM is a medical device that received FDA 510(k) clearance on 2007-09-17. The listed applicant is Mondeal Medical Systems GmbH. The 510(k) number is K071797.

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

MONDEAL HAND CONTOUR SYSTEM received FDA 510(k) clearance on 2007-09-17, under 510(k) number K071797.

Who is the listed applicant for MONDEAL HAND CONTOUR SYSTEM?

The FDA 510(k) record lists Mondeal Medical Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

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.

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Other records listing Mondeal Medical Systems GmbH 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.

K072740MONDEAL EXTREMITY BONE FIXATION SYSTEMK071798MONDEAL DISTAL RADIUS SYSTEMK062436SIS SINUS IMPLANT STABILIZERK050257LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)K042345LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)

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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