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 |