The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Novabone Putty-bioactive Synthetic Bone Graft.
| Device ID | K082672 |
| 510k Number | K082672 |
| Device Name: | NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | NovaBone Products, LLC 13709 PROGRESS BLVD., #33 Alachua, FL 32615 |
| Contact | David M Galsser |
| Correspondent | David M Galsser 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 | 2008-09-15 |
| Decision Date | 2008-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813909011134 | K082672 | 000 |
| 00813909012810 | K082672 | 000 |
| 00813909010823 | K082672 | 000 |
| 00813909010830 | K082672 | 000 |
| 00813909010847 | K082672 | 000 |
| 00813909010854 | K082672 | 000 |
| 00813909010939 | K082672 | 000 |
| 00813909011097 | K082672 | 000 |
| 00813909011103 | K082672 | 000 |
| 00813909011110 | K082672 | 000 |
| 00813909011127 | K082672 | 000 |
| 00813909012803 | K082672 | 000 |