THE VAULT SYSTEM
System, Image Processing, Radiological
SOMERSAULT ORTHOPEDICS, INC.
The following data is part of a premarket notification filed by Somersault Orthopedics, Inc. with the FDA for The Vault System.
Pre-market Notification Details
| Device ID | K124051 |
| 510k Number | K124051 |
| Device Name: | THE VAULT SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | SOMERSAULT ORTHOPEDICS, INC. 2800 PLEASANT HILL ROAD, SUITE 175 Pleasant Hill, CA 94523 |
| Contact | Pamela M Buckman |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-12-31 |
| Decision Date | 2013-05-17 |
| Summary: | summary |
Trademark Results [THE VAULT SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THE VAULT SYSTEM 86226139 4636421 Live/Registered |
UNIK ORTHOPEDICS, INC. 2014-03-19 |
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