FDA.reportPublic FDA data

ONKOS SURGICAL, INC.

Matched from indexed company URL: Onkos Surgical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30134509373013450937ONKOS SURGICAL, INC.1N2026-01-0177 E HALSEY RD Parsippany NJ US 07054

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B278HC1512003M0ELEOS Limb Salvage System With BioGrip - SEGMENTAL COLLAR STEM, CEMENTED, 15MM X 120MM+1(844)767-2766customerservice@onkossurgical.com
B278HC1712003M0ELEOS Limb Salvage System With BioGrip - SEGMENTAL COLLAR STEM, CEMENTED, 17MM X 120MM+1(844)767-2766customerservice@onkossurgical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2045462002057812K252920ELEOS™ Limb Salvage System with NanoCept® TechnologyQZZ2025-10-15
2045462065476313K223348My3D® Personalized Pelvic ReconstructionLPH2023-01-30
2045461563313739K212815My3D® Personalized Pelvic ReconstructionLPH2022-07-06
2045461779075988K203815ELEOS Limb Salvage System with BioGripJDI2021-06-09
2045461398849427K203588ELEOS™ Limb Salvage SystemJDI2021-02-05
2045461004733552K203090ELEOS Limb Salvage System featuring BIOGRIPJDI2020-12-11
2045461077380897K161520ELEOS Limb Salvage SystemKRO2016-10-28
2045461758164686K133152JTS EXTENDIBLE DISTAL FEMORAL IMPLANTKRO2014-01-22
2045461241219659K092138JTS EXTENDEABLE IMPLANTKRO2011-03-22
2045461031901436DEN210058ELEOSx™ Limb Salvage SystemQZZ2024-04-05
2045461178166421
2045461830452542

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JDI32021-06-09
KRO32016-10-28
QZZ22025-10-15
LPH22023-01-30

PMN#

GUDID#

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