BOND BONE
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 Bone.
Pre-market Notification Details
| Device ID | K083858 |
| 510k Number | K083858 |
| Device Name: | BOND BONE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | AUGMA BIOMATERIALS, LTD. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | David J Collette |
| Correspondent | David J Collette 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 | 2008-12-24 |
| Decision Date | 2009-03-17 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290014838014 | K083858 | 000 |
| 17290014838007 | K083858 | 000 |
| 07290014838055 | K083858 | 000 |
| 07290014838062 | K083858 | 000 |
| 07290014838215 | K083858 | 000 |
| 07290014838208 | K083858 | 000 |
| 07290014838192 | K083858 | 000 |
| 07290014838185 | K083858 | 000 |
| 07290014838178 | K083858 | 000 |
Trademark Results [BOND BONE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BOND BONE 77552842 3920202 Live/Registered |
MIS IMPLANTS TECHNOLOGIES LTD. 2008-08-21 |
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