The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive Composite.
| Device ID | K140946 |
| 510k Number | K140946 |
| Device Name: | NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | NovaBone Products, LLC 13510 NW US Highway 441 Alachua, FL 32615 |
| Contact | Lisa Simpson |
| Correspondent | Lisa Simpson NovaBone Products, LLC 13510 NW US Highway 441 Alachua, FL 32615 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-14 |
| Decision Date | 2014-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813909011202 | K140946 | 000 |
| 00813909010786 | K140946 | 000 |
| 00813909010793 | K140946 | 000 |
| 00813909010809 | K140946 | 000 |
| 00813909010816 | K140946 | 000 |
| 00813909011165 | K140946 | 000 |
| 00813909011172 | K140946 | 000 |
| 00813909011189 | K140946 | 000 |
| 00813909011196 | K140946 | 000 |
| 00813909010410 | K140946 | 000 |