FDA.reportPublic FDA data

Gaudi

Primary DI
G682G0135361
Brand
Gaudi
Company
NETBIOLOGICS, LLC
Model
Proximal Humerus Plate Fixation Screw
Catalog number
G01-3536
Device description
Fixation Screw, for Gaudi Plate, OD=3.5mm, LEN=36mm
Published
2025-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
G682G0135361PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
941-518-9248contact@netbiologics.com

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
G682G02R0951GaudiProximal Humerus PlateG02-R0952026-05-14
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
G682G0135481GaudiProximal Humerus Plate Fixation ScrewG01-35482025-05-14

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Primary DI, Brand, Company table
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