FDA Registration
Active
🇨🇭 Switzerland
OMEGA PLUS SIDEPLATE 130X5 SLOT
Reg #: 3010158639
·
FEI: 3010158639
·
Expires 2025
Products
1
Proprietary Names
25
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MAWATEC AG
- Registration Number
- 3010158639
- FEI Number
- 3010158639
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Selzacherstrasse 32
- City
- Selzach Solothurn
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K955306
Owner / Operator
- Firm Name
- Mawatec AG
- Operator Number
- 10043561
- Address
- Selzacherstrasse 32
- City
- Selzach
- State
- Solothurn
- Postal Code
- 2545
- Country
- CH
- Correspondent
- Dominik Lehmann
US Agent
- Business Name
- EMERGO GLOBAL REPRESENTATION LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Caves Rd Ste 1 Ste 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-02-27 |
Proprietary Names
OMEGA PLUS SIDEPLATE 130X5 SLOT
OMEGA PLUS SIDEPLATE 140X2 SLOT
OMEGA PLUS SB SIDEPLATE 135X4 SLOT
OMEGA PLUS SIDEPLATE 135X4 SLOT
OMEGA PLUS SIDEPLATE 130X4 SLOT
OMEGA PLUS SIDEPLATE 145X3 SLOT
OMEGA PLUS SUPRA PLATE 98X8 SLOT KEYED
OMEGA PLUS SIDEPLATE 135X2 SLOT
OMEGA PLUS SUPRA PLATE 98X14 SLOT KEYED
OMEGA PLUS SIDEPLATE 140X4 SLOT
OMEGA PLUS SIDEPLATE 150X3 SLOT
OMEGA PLUS SUPRA PLATE 98X10 SLOT KEYED
OMEGA PLUS SIDEPLATE 130X3 SLOT
OMEGA PLUS SIDEPLATE 130X6 SLOT
OMEGA PLUS SIDEPLATE 135X3 SLOT
OMEGA PLUS SIDEPLATE 130X2 SLOT
OMEGA PLUS SUPRA PLATE 98X6 SLOT KEYED
OMEGA PLUS SIDEPLATE 140X3 SLOT
OMEGA PLUS SUPRA PLATE 98X12 SLOT KEYED
OMEGA PLUS SIDEPLATE 150X4 SLOT
OMEGA PLUS SIDEPLATE 135X5 SLOT
OMEGA PLUS SIDEPLATE 140X5 SLOT
OMEGA PLUS SIDEPLATE 145X4 SLOT
OMEGA PLUS SIDEPLATE 135X6 SLOT
OMEGA PLUS SB SIDEPLATE 135X5 SLOT
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)