EmbedMed
Driver, Wire, And Bone Drill, Manual
3D LifePrints UK Ltd.
The following data is part of a premarket notification filed by 3d Lifeprints Uk Ltd. with the FDA for Embedmed.
Pre-market Notification Details
| Device ID | K220366 |
| 510k Number | K220366 |
| Device Name: | EmbedMed |
| Classification | Driver, Wire, And Bone Drill, Manual |
| Applicant | 3D LifePrints UK Ltd. The Innovation Hub, Alder Hey Children's NHS Foundation Trust, Eaton Road West Derby, Liverpool, Merseyside, GB L12 2AP |
| Contact | Henry Pinchbeck |
| Correspondent | Sam Murray Olympus Regulatory Solutions 5 Seaconnet Ave Portsmouth, RI 02871 |
| Product Code | DZJ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-08 |
| Decision Date | 2022-09-30 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009815704 | K220366 | 000 |
| 00860009815735 | K220366 | 000 |
| 00860009815728 | K220366 | 000 |
| 00860009815711 | K220366 | 000 |
Trademark Results [EmbedMed]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EMBEDMED 90815959 not registered Live/Pending |
3D Lifeprints UK Limited 2021-07-07 |
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