FDA Registration
Active
🇩🇪 Germany
ARMBRUSTER GMBH
Reg #: 3013194153
·
FEI: 3013194153
·
Expires 2026
Products
35
Proprietary Names
0
Establishment Types
1
Classifications
35
Registration Details
- Registration Name
- ARMBRUSTER GMBH
- Registration Number
- 3013194153
- FEI Number
- 3013194153
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Josef-Maier-Str. 6
- City
- Steinach Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- Armbruster GmbH
- Operator Number
- 10054478
- Address
- Josef-Maier-Str. 6
- City
- Steinach
- State
- Baden-Wurttemberg
- Postal Code
- 77790
- Country
- DE
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-04-29 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2019-05-27 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2019-05-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2019-05-27 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-11-14 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2020-03-03 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2025-04-29 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2019-05-27 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-07-18 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2025-01-31 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2025-01-31 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2019-06-21 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-01-30 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-01-26 |
| Bone Wedge | PLF | Class 2 | Orthopedic | No | 2023-01-26 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2017-03-23 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2017-05-30 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2023-11-07 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2023-03-16 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2025-01-30 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2018-02-21 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2025-01-30 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2025-01-30 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2025-01-30 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2022-12-19 |
| Goniometer, Nonpowered | KQW | Class 1 | Orthopedic | No | 2025-01-30 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2025-02-03 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2025-01-31 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2019-05-27 |
| Template | HWT | Class 1 | Orthopedic | No | 2022-12-19 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-01-23 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2025-01-31 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2023-11-07 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2025-01-31 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2019-05-27 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)