FDA Registration
Active
🇺🇸 United States
proprietary
Reg #: 3010047454
·
FEI: 3010047454
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CULVER TOOL & ENGINEERING
- Registration Number
- 3010047454
- FEI Number
- 3010047454
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1901 Walter Glaub Dr, 2121 Walter Glaub Dr
- City
- Plymouth
- State
- IN
- ZIP
- 46563
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151198
Owner / Operator
- Firm Name
- Culver Tool & Engineering LLC dba SpiTrex CTE
- Operator Number
- 10043008
- Address
- 2121 Walter Glaub Dr
- City
- Plymouth
- State
- IN
- Postal Code
- 46563
- Country
- US
- Correspondent
- Heather R Houin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2019-01-09 |
Proprietary Names
proprietary
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)