FDA Registration
Active
🇺🇸 United States
Elevation Spine
Reg #: 3019248313
·
FEI: 3019248313
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- REALIZED MFG
- Registration Number
- 3019248313
- FEI Number
- 3019248313
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 879 S. Progress Drive, Suite A
- City
- Medina
- State
- OH
- ZIP
- 44256
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190885
Owner / Operator
- Firm Name
- Realized Mfg.
- Operator Number
- 10084896
- Address
- 879 S. Progress Drive, Suite A
- City
- Medina
- State
- OH
- Postal Code
- 44256
- Country
- US
- Correspondent
- Michael Rappach
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-03-18 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2025-03-18 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-03-18 |
Proprietary Names
Elevation Spine
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)