My3D® Personalized Pelvic Reconstruction

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

Onkos Surgical

The following data is part of a premarket notification filed by Onkos Surgical with the FDA for My3d® Personalized Pelvic Reconstruction.

Pre-market Notification Details

Device IDK212815
510k NumberK212815
Device Name:My3D® Personalized Pelvic Reconstruction
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant Onkos Surgical 77 East Halsey Rd. Parsippany,  NJ  07054
ContactMatthew Vernak
CorrespondentMatthew Vernak
Onkos Surgical 77 East Halsey Rd. Parsippany,  NJ  07054
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-03
Decision Date2022-07-06

Trademark Results [My3D]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MY3D
MY3D
87981909 5904299 Live/Registered
Onkos Surgical, Inc.
2017-04-24
MY3D
MY3D
87422570 not registered Live/Pending
Onkos Surgical, Inc.
2017-04-24
MY3D
MY3D
86386459 5176789 Live/Registered
David G. Capper
2014-09-05
MY3D
MY3D
85120654 not registered Dead/Abandoned
HASBRO, INC.
2010-09-01

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