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 | K101860 |
| 510k Number | K101860 |
| Device Name: | NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | NovaBone Products, LLC 13631 PROGRESS BLVD SUITE 600 Alachua, FL 32615 |
| Contact | David M Galsser |
| Correspondent | David M Galsser NovaBone Products, LLC 13631 PROGRESS BLVD SUITE 600 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 | 2010-07-02 |
| Decision Date | 2010-09-01 |
| Summary: | summary |