FDA.reportPublic FDA data

Gaudi

Primary DI
G682G0135221
Brand
Gaudi
Company
NETBIOLOGICS, LLC
Model
Proximal Humerus Plate Fixation Screw
Catalog number
G01-3522
Device description
Fixation Screw, for Gaudi Plate, OD=3.5mm, LEN=22mm
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, 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
G682G0135221PrimaryHIBCC0

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
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G682G0135141GaudiProximal Humerus Plate Fixation ScrewG01-35142025-05-14
G682G0135181GaudiProximal Humerus Plate Fixation ScrewG01-35182025-05-14
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
G682G0140480GaudiProximal Humerus Plate Fixation ScrewG01-40482025-05-14
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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Primary DI, Brand, Company table
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07640187463422POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, RightBonebridge AGHRS2026-05-22
07640187463439POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, LeftBonebridge AGHRS2026-05-22
07640187463446POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, RightBonebridge AGHRS2026-05-22
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