The following data is part of a premarket notification filed by Bioventus with the FDA for Signafuse Bioactive Bone Graft.
| Device ID | K193513 |
| 510k Number | K193513 |
| Device Name: | SIGNAFUSE Bioactive Bone Graft |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Bioventus 4721 Emperor Blvd, Suite 100 Durham, NC 27703 |
| Contact | Kim Patterson Kelly |
| Correspondent | Christine Scifert MRC-X, LLC 6075 Poplar Ave Memphis, TN 38119 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-19 |
| Decision Date | 2020-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816986020518 | K193513 | 000 |
| 00816986020501 | K193513 | 000 |
| 00816986020495 | K193513 | 000 |
| 00816986020488 | K193513 | 000 |