BOND APATITE
Bone Grafting Material, Synthetic
AUGMA BIOMATERIALS, LTD.
The following data is part of a premarket notification filed by Augma Biomaterials, Ltd. with the FDA for Bond Apatite.
Pre-market Notification Details
| Device ID | K121177 |
| 510k Number | K121177 |
| Device Name: | BOND APATITE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | AUGMA BIOMATERIALS, LTD. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Kevin A Thomas |
| Correspondent | Kevin A Thomas AUGMA BIOMATERIALS, LTD. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-18 |
| Decision Date | 2013-12-05 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290108992533 | K121177 | 000 |
| 07290108992526 | K121177 | 000 |
Trademark Results [BOND APATITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BOND APATITE 85450734 4495220 Live/Registered |
Augma Biomaterials 2011-10-19 |
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