FDA Registration
Active
🇩🇪 Germany
PTUMEDICAL GMBH
Reg #: 3016237080
·
FEI: 3016237080
·
Expires 2026
Products
25
Proprietary Names
0
Establishment Types
1
Classifications
25
Registration Details
- Registration Name
- PTUMEDICAL GMBH
- Registration Number
- 3016237080
- FEI Number
- 3016237080
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Hermann-Winker-Str. 7
- City
- Spaichingen Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- PTUmedical GmbH
- Operator Number
- 10062025
- Address
- Hermann-Winker-Str. 7
- City
- Spaichingen
- State
- Baden-Wurttemberg
- Postal Code
- 78549
- Country
- DE
- Correspondent
- Tevfik Uzun
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 |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2022-04-01 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-12-12 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2022-04-25 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2023-12-13 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2021-02-02 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-03-17 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-03-17 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2025-03-17 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2020-09-16 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2025-06-03 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-02-10 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2023-01-23 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2024-01-11 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2020-08-12 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2025-06-10 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2021-02-02 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2020-11-09 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2019-12-12 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2019-12-12 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-01-16 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2020-08-12 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-04-01 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2026-02-16 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2021-10-29 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2024-04-04 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)