The following data is part of a premarket notification filed by Osteobiologics, Inc. with the FDA for Polygraft Tcp Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-xx, 600-025-xx, 600-026-xx, 600-022-xx, 600-027-xx.
| Device ID | K033707 |
| 510k Number | K033707 |
| Device Name: | POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | OSTEOBIOLOGICS, INC. UNIVERSITY BUSINESS PARK 12500 NETWORK, SUITE 112 San Antonio, TX 78249 -3308 |
| Contact | Gabriele G Niederauer, Ph.d. |
| Correspondent | Gabriele G Niederauer, Ph.d. 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-26 |
| Decision Date | 2004-08-16 |
| Summary: | summary |