FDA Registration Active 🇩🇪 Germany

Localizer Bone Anchor

Reg #: 3010313588 · FEI: 3010313588 · Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Fiagon GMBH
Registration Number
3010313588
FEI Number
3010313588
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Neuendorfstr. 23b
City
Hennigsdorf Brandenburg
Country
DE

Regulatory Submissions

510(k) Number
K163209

Owner / Operator

Firm Name
Fiagon GmbH
Operator Number
10046786
Address
Neuendorfstr. 23b
City
Hennigsdorf
State
Brandenburg
Postal Code
16761
Country
DE

US Agent

Business Name
Fiagon NA
Contact Name
Matthew Jones
Address
3913 Todd Lane, Suite 101
City
Austin
State
TX
ZIP
78744
Country
US
Phone
512 3838580

Products

Device Name Product Code
Neurological Stereotaxic Instrument HAW

Proprietary Names

Localizer Bone Anchor Localizer Adhesive Pad ShuntPointer BiopsyPointer 250 BiopsyPointer 190 Navigation Unit

Establishment Types

Manufacture Medical Device