FDA.report

510(k) K241296

Device
Gaudi Proximal Humerus Plate
Applicant
Netbiologics, LLC
510(k) number
K241296
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-23
Date received
2024-05-08
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Avinash Kumar
Address
7912 Treesdale Gln Lakewood Ranch FL US 34202 34202

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
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G682G0135261GaudiNETBIOLOGICS, LLC2025-05-14
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G682G02L0951GaudiNETBIOLOGICS, LLC2025-05-14
G682G0140261GaudiNETBIOLOGICS, LLC2025-05-14
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G682G0140301GaudiNETBIOLOGICS, LLC2025-05-14
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G682G0140381GaudiNETBIOLOGICS, LLC2025-05-14
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G682G0140480GaudiNETBIOLOGICS, LLC2025-05-14
G682G02L0710GaudiNETBIOLOGICS, LLC2025-05-14
G682G02L0711GaudiNETBIOLOGICS, LLC2025-05-14

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