VELYS™ Robotic-Assisted Solution
Orthopedic Stereotaxic Instrument
DePuy Ireland UC
The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Velys™ Robotic-assisted Solution.
Pre-market Notification Details
| Device ID | K202769 |
| 510k Number | K202769 |
| Device Name: | VELYS™ Robotic-Assisted Solution |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | DePuy Ireland UC Loughbeg Ringaskiddy, IE |
| Contact | Erin Combs |
| Correspondent | Stephanie Elvin DePuy Ireland UC Loughbeg Ringaskiddy, IE |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-21 |
| Decision Date | 2021-01-14 |
Trademark Results [VELYS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VELYS 88477727 not registered Live/Pending |
Depuy Synthes, Inc. 2019-06-18 |
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