FDA.reportPublic FDA data

Gaudi

Primary DI
G682G02R0951
Brand
Gaudi
Company
NETBIOLOGICS, LLC
Model
Proximal Humerus Plate
Catalog number
G02-R095
Published
2026-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241296000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241296000Gaudi Proximal Humerus PlateNetbiologics, LLC2024-07-23HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G682G02R0951PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
071462633
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G682G0135241GaudiProximal Humerus Plate Fixation ScrewG01-35242026-05-14
G682G013532GaudiProximal Humerus Plate Fixation ScrewG01-35322026-05-14
G682G0135381GaudiProximal Humerus Plate Fixation ScrewG01-35382026-05-14
G682G0135401GaudiProximal Humerus Plate Fixation ScrewG01-35402026-05-14
G682G0135421GaudiProximal Humerus Plate Fixation ScrewG01-35422026-05-14
G682G0135441GaudiProximal Humerus Plate Fixation ScrewG01-35442026-05-14
G682G0135461GaudiProximal Humerus Plate Fixation ScrewG01-35462026-05-14
G682G013550GaudiProximal Humerus Plate Fixation ScrewG01-35502026-05-14
G682G0140321GaudiProximal Humerus Plate Fixation ScrewG01-40322026-05-14
G682G0135521GaudiProximal Humerus Plate Fixation ScrewG01-35522026-05-12
G682G02R0711GaudiProximal Humerus Plate Fixation ScrewG02-R0712025-05-14
G682G0135141GaudiProximal Humerus Plate Fixation ScrewG01-35142025-05-14
G682G0135181GaudiProximal Humerus Plate Fixation ScrewG01-35182025-05-14
G682G0135221GaudiProximal Humerus Plate Fixation ScrewG01-35222025-05-14
G682G0135261GaudiProximal Humerus Plate Fixation ScrewG01-35262025-05-14
G682G0135281GaudiProximal Humerus Plate Fixation ScrewG01-35282025-05-14
G682G0135301GaudiProximal Humerus Plate Fixation ScrewG01-35302025-05-14
G682G0135341GaudiProximal Humerus Plate Fixation ScrewG01-35342025-05-14
G682G0135361GaudiProximal Humerus Plate Fixation ScrewG01-35362025-05-14
G682G0135481GaudiProximal Humerus Plate Fixation ScrewG01-35482025-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809986490018CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490025CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490032CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490049CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490056CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490063CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490087CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490094CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490100CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490117CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490124CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490131CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490148CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490155CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490162CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490179CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490186CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490193CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490209CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490216CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490223CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490230CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490247CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490254CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490261CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490278CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490285CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490292CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27
08809986490308CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-05-27