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 ID | K212815 |
| 510k Number | K212815 |
| Device Name: | My3D® Personalized Pelvic Reconstruction |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Onkos Surgical 77 East Halsey Rd. Parsippany, NJ 07054 |
| Contact | Matthew Vernak |
| Correspondent | Matthew Vernak Onkos Surgical 77 East Halsey Rd. Parsippany, NJ 07054 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-03 |
| Decision Date | 2022-07-06 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B278DG6512004N0 | K212815 | 000 |
| B278DGCS02004N0 | K212815 | 000 |
| B278AMM3DMD04N0 | K212815 | 000 |
| B278AMC3DMD04N0 | K212815 | 000 |
| B278DR4320004N0 | K212815 | 000 |
| B278DR4305004N0 | K212815 | 000 |
| B278DR4302504N0 | K212815 | 000 |
| B278PVTRYLD04T0 | K212815 | 000 |
| B278PVTRAY204T0 | K212815 | 000 |
| B278PVTRAY104T0 | K212815 | 000 |
| B278PV65TRY04T0 | K212815 | 000 |
| B278HD35TRQ04N0 | K212815 | 000 |
| B278HDSP03604N0 | K212815 | 000 |
| B278PVACREC04M0 | K212815 | 000 |
| B278DVRGDMD04N0 | K212815 | 000 |
| B278DVFLXMD04N0 | K212815 | 000 |
| B278SF6500004N0 | K212815 | 000 |
| B278HDBP33204N0 | K212815 | 000 |
| B278EX3506504N0 | K212815 | 000 |
| B278TP65180040 | K212815 | 000 |
| B278TP6505004N0 | K212815 | 000 |
| B278TP6502504N0 | K212815 | 000 |
| B278PVGUIDE04N0 | K212815 | 000 |
| B278PVAPRCN04M0 | K212815 | 000 |
| B278AP3801604M0 | K212815 | 000 |
Trademark Results [My3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MY3D 87981909 5904299 Live/Registered |
Onkos Surgical, Inc. 2017-04-24 |
 MY3D 87422570 not registered Live/Pending |
Onkos Surgical, Inc. 2017-04-24 |
 MY3D 86386459 5176789 Live/Registered |
David G. Capper 2014-09-05 |
 MY3D 85120654 not registered Dead/Abandoned |
HASBRO, INC. 2010-09-01 |
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