FDA Registration
Active
🇨🇭 Switzerland
Monarch Spine System
Reg #: 3015831087
·
FEI: 3015831087
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Jabil Switzerland Manufacturing GmbH (Le Locle)
- Registration Number
- 3015831087
- FEI Number
- 3015831087
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Chemin Blanc 36 - 38
- City
- Le Locle Neuchatel
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K010576
Owner / Operator
- Firm Name
- Jabil Inc.
- Operator Number
- 9074019
- Address
- 10800 Roosevelt Blvd.
- City
- Saint Petersburg
- State
- FL
- Postal Code
- 33716
- Country
- US
US Agent
- Business Name
- JABIL - NYPRO HEALTHCARE DIVISION
- Contact Name
- Lex Pearce
- Address
- 3801 University Blvd, SE
- City
- Albuquerque
- State
- NM
- ZIP
- 87106
- Country
- US
- [email protected]
- Phone
- 505 2030277
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-09-23 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2019-09-23 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2019-09-23 |
Proprietary Names
Monarch Spine System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)