STANSION MATRIX
Spinal Vertebral Body Replacement Device
SPINEWORKS, LLC
The following data is part of a premarket notification filed by Spineworks, Llc with the FDA for Stansion Matrix.
Pre-market Notification Details
| Device ID | K042600 |
| 510k Number | K042600 |
| Device Name: | STANSION MATRIX |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SPINEWORKS, LLC 555 13TH STREET N.W. Washington, DC 20004 |
| Contact | Jonathan Kahan |
| Correspondent | Jonathan Kahan SPINEWORKS, LLC 555 13TH STREET N.W. Washington, DC 20004 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-23 |
| Decision Date | 2005-02-18 |
| Summary: | summary |
Trademark Results [STANSION MATRIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STANSION MATRIX 77093983 3561658 Live/Registered |
INNOVASIS, INC. 2007-01-29 |
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