FDA Registration
Active
🇺🇸 United States
INTEGRATE-C Interbody Fusion System
Reg #: 1836116
·
FEI: 3002687954
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- REVELATION MEDICAL DEVICES, LLC
- Registration Number
- 1836116
- FEI Number
- 3002687954
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1105 West Auburn Street
- City
- Auburn
- State
- IN
- ZIP
- 46706
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222004
Owner / Operator
- Firm Name
- REVELATION MEDICAL DEVICES LLC
- Operator Number
- 10051413
- Address
- 1105 WEST AUBURN DRIVE
- City
- Auburn
- State
- IN
- Postal Code
- 46706
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2023-08-01 |
Proprietary Names
INTEGRATE-C Interbody Fusion System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)