NOVABONE BIOACTIVE STRIP
Filler, Bone Void, Calcium Compound
NovaBone Products, LLC
The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Novabone Bioactive Strip.
Pre-market Notification Details
| Device ID | K141207 |
| 510k Number | K141207 |
| Device Name: | NOVABONE BIOACTIVE STRIP |
| 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 | 2014-05-09 |
| Decision Date | 2014-10-31 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813909011011 | K141207 | 000 |
| 00813909011004 | K141207 | 000 |
| 00813909010991 | K141207 | 000 |
| 00813909010984 | K141207 | 000 |
| 00813909010977 | K141207 | 000 |
| 00813909012872 | K141207 | 000 |
| 00813909012865 | K141207 | 000 |
Trademark Results [NOVABONE BIOACTIVE STRIP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVABONE BIOACTIVE STRIP 86238998 4769883 Live/Registered |
NovaBone Products, LLC 2014-04-01 |
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