The following data is part of a premarket notification filed by Osteobiologics, Inc. with the FDA for Polygraft Bgs; Bone Graft Substitute.
| Device ID | K041382 |
| 510k Number | K041382 |
| Device Name: | POLYGRAFT BGS; BONE GRAFT SUBSTITUTE |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | OSTEOBIOLOGICS, INC. 12500 NETWORK SUITE 112 San Antonio, TX 78249 |
| Contact | Gabriele G Niederauer, Ph.d. |
| Correspondent | Gabriele G Niederauer, Ph.d. OSTEOBIOLOGICS, INC. 12500 NETWORK SUITE 112 San Antonio, TX 78249 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-25 |
| Decision Date | 2005-06-17 |
| Summary: | summary |