The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Novabone Porous - Synthetic Bone Graft Scaffold.
| Device ID | K090731 |
| 510k Number | K090731 |
| Device Name: | NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | NovaBone Products, LLC 13709 PROGRESS BLVD., #33 Alachua, FL 32615 |
| Contact | David M Gaisser |
| Correspondent | David M Gaisser NovaBone Products, LLC 13709 PROGRESS BLVD., #33 Alachua, FL 32615 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-19 |
| Decision Date | 2009-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813909011226 | K090731 | 000 |
| 00813909012926 | K090731 | 000 |
| 00813909010908 | K090731 | 000 |
| 00813909010915 | K090731 | 000 |
| 00813909010922 | K090731 | 000 |
| 00813909010946 | K090731 | 000 |
| 00813909010953 | K090731 | 000 |
| 00813909010960 | K090731 | 000 |
| 00813909011141 | K090731 | 000 |
| 00813909011158 | K090731 | 000 |
| 00813909011219 | K090731 | 000 |
| 00813909012919 | K090731 | 000 |