FDA Registration
Active
🇮🇹 Italy
BRM EXTREMITIES SRL
Reg #: 3016669046
·
FEI: 3016669046
·
Expires 2026
Products
6
Proprietary Names
17
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- BRM EXTREMITIES SRL
- Registration Number
- 3016669046
- FEI Number
- 3016669046
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Privata ai Campi, 7
- City
- Civate (LC) Lombardy
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K203773
Owner / Operator
- Firm Name
- BRM EXTREMITIES
- Operator Number
- 10062707
- Address
- Via Lorenzo Mascheroni, 29
- City
- Milano
- State
- Lombardy
- Postal Code
- 20145
- Country
- IT
- Correspondent
- Lisa Fazzini
US Agent
- Business Name
- MCRA, LLC
- Contact Name
- Margeaux Rogers
- Address
- 1050 K Street, Suite 1000
- City
- Washington
- State
- DC
- ZIP
- 20001
- Country
- US
- [email protected]
- Phone
- 202 5525805
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2020-03-10 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-11-17 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2020-03-10 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-04-04 |
| Prosthesis, Finger, Constrained, Polymer | KYJ | Class 2 | Orthopedic | No | 2023-04-19 |
| Prosthesis, Toe, Constrained, Polymer | KWH | Class 2 | Orthopedic | No | 2020-03-10 |
Proprietary Names
Percutaneous Burrs
BRM TOOL VIP SCREWS
BRM VR BREAKING SCREWS
BRM TOOL SCREWS
BRM TOOL PRO 7 SCREWS
Silktoe Instruments
BRM VR Breaking Screws Instruments
Digitalis Instruments
Tool Instruments
Tool Pro Instruments
Tool Vip Instruments
BioPlan Instruments
BRM DRILL BIT
BRM DIGITALIS Spacer
BRM BIOPLAN SUBTALAR IMPLANT
BRM TOOL PRO 5.6 SCREWS
Silktoe Spacer
Establishment Types
Manufacture Medical Device