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FDA 510(k)

GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM

K-Number: K092493 · 2010-03-29

ApplicantGpc Medical, Ltd.
Decision Date2010-03-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gpc Medical, Ltd.. It received FDA 510(k) clearance on 2010-03-29 under 510(k) number K092493. 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 GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM?

GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-03-29. The listed applicant is Gpc Medical, Ltd.. The 510(k) number is K092493.

When did GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM receive FDA 510(k) clearance?

GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM received FDA 510(k) clearance on 2010-03-29, under 510(k) number K092493.

Who is the listed applicant for GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM?

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

What is the FDA product code for GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM?

The FDA product code for GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM is HRS.

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Other records listing Gpc Medical, Ltd. 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.

K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.

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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