The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Vitoss-filled Cartridge.
| Device ID | K032130 |
| 510k Number | K032130 |
| Device Name: | VITOSS-FILLED CARTRIDGE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Andreina Angie Ide |
| Correspondent | Andreina Angie Ide ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-11 |
| Decision Date | 2003-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00808232000108 | K032130 | 000 |
| 00808232000092 | K032130 | 000 |
| 00808232000085 | K032130 | 000 |
| 00808232000078 | K032130 | 000 |
| 00808232000061 | K032130 | 000 |
| 00808232000054 | K032130 | 000 |
| 00808232000047 | K032130 | 000 |
| 00808232000030 | K032130 | 000 |