The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Vitomatrix.
Device ID | K091618 |
510k Number | K091618 |
Device Name: | VITOMATRIX |
Classification | Bone Grafting Material, Synthetic |
Applicant | ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
Contact | Deborah L Jackson |
Correspondent | Deborah L Jackson ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
Product Code | LYC |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-03 |
Decision Date | 2010-09-27 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VITOMATRIX 85532422 4429373 Live/Registered |
Orthovita, Inc. 2012-02-02 |
VITOMATRIX 77876405 4376731 Live/Registered |
Orthovita, Inc. 2009-11-19 |
VITOMATRIX 76361114 not registered Dead/Abandoned |
Vita Licensing, Inc. 2002-01-18 |