The following data is part of a premarket notification filed by Silony Medical Gmbh with the FDA for Roccia® Acif.
| Device ID | K162587 | 
| 510k Number | K162587 | 
| Device Name: | ROCCIA® ACIF | 
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical | 
| Applicant | SILONY MEDICAL GMBH LEINFELDER STRASSE 60 Leinfelden-echterdingen, DE 70771 | 
| Contact | Bircan Yilmaz | 
| Correspondent | Richard A. Vincins Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 | 
| Product Code | ODP | 
| CFR Regulation Number | 888.3080 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2016-09-16 | 
| Decision Date | 2017-01-26 | 
| Summary: | summary | 
| 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 |