FDA.reportPublic FDA data

Gaudi

Primary DI
G682G0135141
Brand
Gaudi
Company
NETBIOLOGICS, LLC
Model
Proximal Humerus Plate Fixation Screw
Catalog number
G01-3514
Device description
Fixation screw for Gaudi Proximal Humerus Plate, 3.5 diameter X 14mm length
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
G682G0135141PrimaryHIBCC0

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. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Millimeter
Outer Diameter3.5Millimeter

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
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
05055662970890ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWC2026-07-10
05055662971514ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWC2026-07-10
00190446944331Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446944348Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952213Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952220Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952237Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952244Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952251Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952268Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952275Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952282Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952299Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952305Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952312Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952329Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00885556904879EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556904923EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906163EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906170EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906187EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906194EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906200EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906217EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906224EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906231EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906248EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906255EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906262EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906279EVOSSmith & Nephew, Inc.HWC2026-06-25