FDA Registration Active 🇺🇸 United States

Navigated EXPEDIUM 5.5 Extended Driver Sleeve

Reg #: 1834379 · FEI: 1000306303 · Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1

Registration Details

Registration Name
MICROPULSE INC
Registration Number
1834379
FEI Number
1000306303
Status
Active
Expiry Year
2025
Initial Importer
No
Address
5865 E State Road 14
City
Columbia City
State
IN
ZIP
46725
Country
US

Regulatory Submissions

510(k) Number
K233255

Owner / Operator

Firm Name
Micropulse
Operator Number
10042100
Address
5865 E State Road 14
City
Columbia City
State
IN
Postal Code
46725
Country
US

Products

Device Name Product Code
Orthopedic Stereotaxic Instrument OLO

Proprietary Names

Navigated EXPEDIUM 5.5 Extended Driver Sleeve Navigated EXPEDIUM 4.5 Driver Shaft SCREWDRIVER - T27 NAV CANNULATED Navigated EXPEDIUM 5.5 Driver Shaft SCREWDRIVER - T27 NAV RETAINING SLEEVE – LONG Navigated EXPEDIUM 5.5 Driver Sleeve Navigated EXPEDIUM 4.5 Driver Sleeve

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)