The following data is part of a premarket notification filed by Osteobiologics, Inc. with the FDA for Polygraft Bone Graft Substitute.
| Device ID | K030288 |
| 510k Number | K030288 |
| Device Name: | POLYGRAFT BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | OSTEOBIOLOGICS, INC. UNIVERSITY BUSINESS PARK 12500 NETWORK, SUITE 112 San Antonio, TX 78249 -3308 |
| Contact | Gabriele G Neiderauer |
| Correspondent | Gabriele G Neiderauer OSTEOBIOLOGICS, INC. UNIVERSITY BUSINESS PARK 12500 NETWORK, SUITE 112 San Antonio, TX 78249 -3308 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-28 |
| Decision Date | 2003-07-17 |
| Summary: | summary |