FDA Registration
Active
🇺🇸 United States
Incite Anchored Cervical Interbody Device
Reg #: 3030708794
·
FEI: 3030708794
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SUMMIT CITY PRECISION MACHINE
- Registration Number
- 3030708794
- FEI Number
- 3030708794
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 815 Lawrence Drive
- City
- Fort Wayne
- State
- IN
- ZIP
- 46804
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150913
Owner / Operator
- Firm Name
- Summit City Precision Machine
- Operator Number
- 10090434
- Address
- 815 Lawrence Drive
- City
- Fort Wayne
- State
- IN
- Postal Code
- 46804
- Country
- US
- Correspondent
- Nick A Acra
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2024-03-27 |
Proprietary Names
Incite Anchored Cervical Interbody Device
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)