Lyograft
Mesh, Surgical
B. Bruan Surgical, SA
The following data is part of a premarket notification filed by B. Bruan Surgical, Sa with the FDA for Lyograft.
Pre-market Notification Details
| Device ID | K192452 |
| 510k Number | K192452 |
| Device Name: | Lyograft |
| Classification | Mesh, Surgical |
| Applicant | B. Bruan Surgical, SA Carretera Terrassa 121 Rubi, ES 08191 |
| Contact | Pau Turon Dols |
| Correspondent | Robin M Fatzinger Qreg Consulting, LLC 2192 Martin Drive Gilbertsville, PA 19525 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-09 |
| Decision Date | 2020-09-03 |
Trademark Results [Lyograft]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LYOGRAFT 97022212 not registered Live/Pending |
Orthofix US LLC 2021-09-10 |
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