ROCCIA® PLIF
Intervertebral Fusion Device With Bone Graft, Lumbar
Silony Medical GmbH
The following data is part of a premarket notification filed by Silony Medical Gmbh with the FDA for Roccia® Plif.
Pre-market Notification Details
| Device ID | K181899 |
| 510k Number | K181899 |
| Device Name: | ROCCIA® PLIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Silony Medical GmbH Leinfelder Strasse 60 Leinfelden-echterdingen, DE 70771 |
| Contact | Bircan Tasdelen |
| Correspondent | Bircan Tasdelen Silony Medical GmbH Leinfelder Strasse 60 Leinfelden-echterdingen, DE 70771 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-16 |
| Decision Date | 2018-12-13 |
| Summary: | summary |
Trademark Results [ROCCIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROCCIA 98198157 not registered Live/Pending |
Turbo Wholesale Holdings, LLC 2023-09-26 |
 ROCCIA 85511670 not registered Dead/Abandoned |
Roccia, Inc. 2012-01-09 |
 ROCCIA 79166429 4861633 Live/Registered |
Silony Medical International AG 2015-02-13 |
 ROCCIA 77101025 not registered Dead/Abandoned |
Roccia, Inc. 2007-02-06 |
 ROCCIA 75876708 2419119 Dead/Cancelled |
CANTINA SOCIALE COOPERATIVA DI LOCOROTONDO SOCIETA COOPERATIVA A RESPONSABILITALIMITATA 1999-12-22 |
 ROCCIA 72455559 0988984 Dead/Expired |
VIBRAM S.P.A. 1973-04-25 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.