The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Novabone Macropor-si+ - Bioactive Bone Graft.
| Device ID | K110925 |
| 510k Number | K110925 |
| Device Name: | NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | NovaBone Products, LLC 13631 PROGRESS BLVD SUITE 600 Alachua, FL 32615 |
| Contact | David M Gaisser |
| Correspondent | David M Gaisser NovaBone Products, LLC 13631 PROGRESS BLVD SUITE 600 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 | 2011-04-01 |
| Decision Date | 2011-07-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813909011080 | K110925 | 000 |
| 00813909011073 | K110925 | 000 |
| 00813909011066 | K110925 | 000 |
| 00813909011059 | K110925 | 000 |
| 00813909011042 | K110925 | 000 |
| 00813909011035 | K110925 | 000 |
| 00813909011028 | K110925 | 000 |
| 00813909010403 | K110925 | 000 |