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 |