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FDA 510(k)

MERETE LOCKING BONE PLATE SYSTEM III

K-Number: K120787 · 2012-11-27

ApplicantMerete Medical GmbH
Decision Date2012-11-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MERETE LOCKING BONE PLATE SYSTEM III is the device name listed in this FDA 510(k) record. The listed applicant is Merete Medical GmbH. It received FDA 510(k) clearance on 2012-11-27 under 510(k) number K120787. 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 MERETE LOCKING BONE PLATE SYSTEM III?

MERETE LOCKING BONE PLATE SYSTEM III is a medical device that received FDA 510(k) clearance on 2012-11-27. The listed applicant is Merete Medical GmbH. The 510(k) number is K120787.

When did MERETE LOCKING BONE PLATE SYSTEM III receive FDA 510(k) clearance?

MERETE LOCKING BONE PLATE SYSTEM III received FDA 510(k) clearance on 2012-11-27, under 510(k) number K120787.

Who is the listed applicant for MERETE LOCKING BONE PLATE SYSTEM III?

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

What is the FDA product code for MERETE LOCKING BONE PLATE SYSTEM III?

The FDA product code for MERETE LOCKING BONE PLATE SYSTEM III is HRS.

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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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