FDA Registration
Active
🇳🇱 Netherlands
Cervical Spine Truss System Plating Solution (CSTS-PS)
Reg #: 3010593798
·
FEI: 3010593798
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INPAKOMED
- Registration Number
- 3010593798
- FEI Number
- 3010593798
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Industrieweg 13 a
- City
- Assendelft Noord-Holland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K212527
Owner / Operator
- Firm Name
- Inpakomed
- Operator Number
- 10045297
- Address
- Industrieweg 13a
- City
- Assendelft
- State
- Noord-Holland
- Postal Code
- 1566JN
- Country
- NL
- Correspondent
- Pieter Bruins
US Agent
- Business Name
- 4WEB, INC
- Contact Name
- John Oldham
- Address
- 2801 Network Blvd Suite 620
- City
- Frisco
- State
- TX
- ZIP
- 75034
- Country
- US
- [email protected]
- Phone
- 214 9983892
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-02-09 |
Proprietary Names
Cervical Spine Truss System Plating Solution (CSTS-PS)
Establishment Types
Repack or Relabel Medical Device