FDA Registration
Active
🇨🇷 Costa Rica
Bone Screw
Reg #: 3003678543
·
FEI: 3003678543
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Biomerics Alajuela
- Registration Number
- 3003678543
- FEI Number
- 3003678543
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SARET INDUSTRIAL PARK, BLDG. D-3, C-7, C-2/C-3, C-4, E-2
- City
- ALAJUELA
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K170698
Owner / Operator
- Firm Name
- Biomerics
- Operator Number
- 10042380
- Address
- 6030 W Harold Gatty Drive
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84116
- Country
- US
- Correspondent
- Jacob J Wakley
US Agent
- Business Name
- Biomerics
- Contact Name
- Jake Wakley
- Address
- 6030 W Harold Gatty Drive
- City
- Salt Lake City
- State
- UT
- ZIP
- 84116
- Country
- US
- [email protected]
- Phone
- 801 3552705
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-12-11 |
Proprietary Names
Bone Screw
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)