FDA Registration
Active
🇩🇪 Germany
GB IMPLANTAT TECHNOLOGIE GMBH
Reg #: 3000258338
·
FEI: 3000258338
·
Expires 2026
Products
8
Proprietary Names
4
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- GB IMPLANTAT TECHNOLOGIE GMBH
- Registration Number
- 3000258338
- FEI Number
- 3000258338
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Gesundheitscampus-Sud 5,
- City
- Bochum North Rhine-Westphalia
- Country
- DE
Owner / Operator
- Firm Name
- gb Implantat Technologie GmbH
- Operator Number
- 10046279
- Address
- Gesundheitscampus-Sud 5,
- City
- Bochum
- State
- North Rhine-Westphalia
- Postal Code
- 45145
- Country
- DE
- Correspondent
- Andreas Piotrowski
US Agent
- Business Name
- Pro Pharma Group
- Contact Name
- Cherita James
- Address
- 1129 20th St Nw Ste 600
- City
- Washington
- State
- DC
- ZIP
- 20036
- Country
- US
- [email protected]
- Phone
- 347 9540624
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2014-02-27 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2014-02-27 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2019-08-14 |
| Total Shoulder Arthroplasty System | QHQ | Class 2 | Orthopedic | No | 2019-08-14 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2018-05-01 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2017-11-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2017-11-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2017-11-03 |
Proprietary Names
Eclipse Implants
CoCr Head -4, CoCr Head Neutral, CoCr Head +4, CoCr Head +8, CoCr Head +12
CoCr Head - Size 36, 40, 44
CoCr Head Neutral, CoCr Head +4, CoCr Head +8, CoCr Head -3.5, CoCr Head Neutral, CoCr Head +3.5, CoCr Head +7, CoCr Hea
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)