Data / Medical devices / Israel / Augma Biomaterials
Augma Biomaterials: FDA-registered device maker in Caesarea Southern Industrial Park Northern, Israel, 2 510(k) clearances
Augma Biomaterials is registered with the FDA (registration 3007490610) in Caesarea Southern Industrial Park Northern, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 5, 2013. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007490610
- Address
- Alon Hatavor 20 St. P.O.Box 3089, Caesarea Southern Industrial Park Northern, Israel, 3088900
- Owner or operator
- Augma Biomaterials (10029027)
- Roles
- Manufacturer
- First device listed
- March 30, 2009
- Registered through
- 2027
- Brand names listed
- 3D Bond, 3D Bond+, Bond Apatite
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 5, 2013 | K121177 | BOND APATITE | LYC | Substantially Equivalent | Augma Biomaterials, Ltd. | accessdata.fda.gov |
| March 17, 2009 | K083858 | BOND BONE | LYC | Substantially Equivalent | Augma Biomaterials, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 5, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.