EASY-GRAFT
Bone Grafting Material, Synthetic
Degradable Solutions AG
The following data is part of a premarket notification filed by Degradable Solutions Ag with the FDA for Easy-graft.
Pre-market Notification Details
| Device ID | K131385 |
| 510k Number | K131385 |
| Device Name: | EASY-GRAFT |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | Degradable Solutions AG 901 KING STREET SUITE 101 Alexandria, VA 22314 |
| Contact | Deborah Lavoie Grayeski |
| Correspondent | Deborah Lavoie Grayeski Degradable Solutions AG 901 KING STREET SUITE 101 Alexandria, VA 22314 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-14 |
| Decision Date | 2013-09-27 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640164360140 | K131385 | 000 |
| 17640164360130 | K131385 | 000 |
| 17640164360123 | K131385 | 000 |
| 17640164360116 | K131385 | 000 |
Trademark Results [EASY-GRAFT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EASY-GRAFT 79066184 3825226 Live/Registered |
SUNSTAR SUISSE SA 2009-02-23 |
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