The following data is part of a premarket notification filed by Orthovita Co. with the FDA for Vitoss Scaffold Synthetic Cancellous Bone Void Filler.
| Device ID | K994337 |
| 510k Number | K994337 |
| Device Name: | VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORTHOVITA CO. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Angie Ide |
| Correspondent | Angie Ide ORTHOVITA CO. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-23 |
| Decision Date | 2000-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00808232000207 | K994337 | 000 |
| 00808232000191 | K994337 | 000 |
| 00808232000153 | K994337 | 000 |
| 00808232000146 | K994337 | 000 |
| 00808232000139 | K994337 | 000 |
| 00808232000122 | K994337 | 000 |
| 00808232000115 | K994337 | 000 |
| 00808232000023 | K994337 | 000 |
| 00808232000016 | K994337 | 000 |