FDA Registration
Active
🇺🇸 United States
ROSA ONE Brain application
Reg #: 1822565
·
FEI: 1000220733
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ZIMMER, INC.
- Registration Number
- 1822565
- FEI Number
- 1000220733
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1800 W. Center Street
- City
- WARSAW
- State
- IN
- ZIP
- 46580
- Country
- US
Regulatory Submissions
- 510(k) Number
- K214065
Owner / Operator
- Firm Name
- ZIMMER, INC.
- Operator Number
- 1822565
- Address
- 345 E. Main Street, --
- City
- Warsaw
- State
- IN
- Postal Code
- 46580
- Country
- US
- Correspondent
- Kevin Escapule
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-07-11 |
Proprietary Names
ROSA ONE Brain application
Establishment Types
Complaint File Establishment per 21 CFR 820.198