The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Novabone-bioactive Synthetic Graft.
| Device ID | K052494 |
| 510k Number | K052494 |
| Device Name: | NOVABONE-BIOACTIVE SYNTHETIC GRAFT |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | NovaBone Products, LLC 13709 PROGRESS BLVD., #33 Alachua, FL 32615 |
| Contact | David M Gaisser |
| Correspondent | David M Gaisser NovaBone Products, LLC 13709 PROGRESS BLVD., #33 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 | 2005-09-12 |
| Decision Date | 2005-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813909012056 | K052494 | 000 |
| 00813909011943 | K052494 | 000 |
| 00813909010892 | K052494 | 000 |
| 00813909010885 | K052494 | 000 |
| 00813909010878 | K052494 | 000 |
| 00813909010861 | K052494 | 000 |