FDA.report

Gaudi

Primary DI
G682G0140480
Brand
Gaudi
Company
NETBIOLOGICS, LLC
Model
Proximal Humerus Plate Fixation Screw
Catalog number
G01-4048
Device description
Fixation Screw, for Gaudi Plate, OD=4.0mm, LEN=48mm
Published
2025-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HRSPlate, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K241296000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K241296000Gaudi Proximal Humerus PlateNetbiologics, LLC2024-07-23HRS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G682G0140480PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
071462633
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
G682G0140141GaudiProximal Humerus Plate Fixation ScrewG01-40142025-05-14
G682G0140201GaudiProximal Humerus Plate Fixation ScrewG01-40202025-05-14
G682G0140261GaudiProximal Humerus Plate Fixation ScrewG0140262025-05-14
G682G0140281GaudiProximal Humerus Plate Fixation ScrewG01-40282025-05-14
G682G0140301GaudiProximal Humerus Plate Fixation ScrewG01-40302025-05-14
G682G0140341GaudiProximal Humerus Plate Fixation ScrewG01-40342025-05-14
G682G0140381GaudiProximal Humerus Plate Fixation ScrewG01-40382025-05-14
G682G0140421GaudiProximal Humerus Plate Fixation ScrewG01-40422025-05-14
G682G02L0710GaudiProximal Humerus Plate Fixation ScrewG02-L0712025-05-14
G682G02L0711GaudiProximal Humerus Plate Fixation ScrewG02-L0712025-05-14
G682G02L0951GaudiProximal Humerus Plate Fixation ScrewG02-L0952025-05-14

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