The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Novabone Macroform Mis Composite - 2.5cc, Novabone Mis Cartridge Delivery System (cartridge Handle Only).
| Device ID | K152071 |
| 510k Number | K152071 |
| Device Name: | NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge Handle Only) |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | NOVABONE PRODUCTS, LLC 13510 NW US HIGHWAY 441 Alachua, FL 32615 |
| Contact | Richard A. Davis |
| Correspondent | Lisa C. Simpson SIMPSON REGULATORY SOLUTIONS, LLC 4401 NW 18TH PLACE Gainesville, FL 32605 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-27 |
| Decision Date | 2015-08-26 |
| Summary: | summary |