The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Novabone Irm.
| Device ID | K163310 |
| 510k Number | K163310 |
| Device Name: | NovaBone IRM |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | NovaBone Products, LLC 13510 NW US Highway 441 Alachua, FL 32615 |
| Contact | Gregory Pomrink |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-23 |
| Decision Date | 2017-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813909011769 | K163310 | 000 |
| 00813909011646 | K163310 | 000 |
| 00813909011653 | K163310 | 000 |
| 00813909011660 | K163310 | 000 |
| 00813909011677 | K163310 | 000 |
| 00813909011691 | K163310 | 000 |
| 00813909011707 | K163310 | 000 |
| 00813909011714 | K163310 | 000 |
| 00813909011721 | K163310 | 000 |
| 00813909011738 | K163310 | 000 |
| 00813909011745 | K163310 | 000 |
| 00813909011639 | K163310 | 000 |