FDA Registration
Active
🇩🇪 Germany
MAXXOS-MEDICAL GMBH
Reg #: 3011354099
·
FEI: 3011354099
·
Expires 2026
Products
13
Proprietary Names
15
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- MAXXOS-MEDICAL GMBH
- Registration Number
- 3011354099
- FEI Number
- 3011354099
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Kirchbuehlstrasse 6
- City
- Mahlstetten Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K251892
Owner / Operator
- Firm Name
- MAXXOS-Medical GmbH
- Operator Number
- 10059877
- Address
- Kirchbuehlstrasse 6
- City
- Mahlstetten
- State
- Baden-Wurttemberg
- Postal Code
- 78601
- Country
- DE
- Correspondent
- Patrick Niebel
US Agent
- Business Name
- Biopro
- Contact Name
- Patrick Pringle
- Address
- 2929 Lapeer Road
- City
- Port Huron
- State
- MI
- ZIP
- 48060
- Country
- US
- [email protected]
- Phone
- 810 9827777 ext. 104
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2025-12-13 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2025-12-13 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2025-12-13 |
| Bender | HXW | Class 1 | Orthopedic | No | 2025-12-13 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-03-04 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2019-03-04 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2025-12-13 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2025-12-13 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2025-12-13 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2025-12-13 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-12-13 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2025-12-13 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2025-12-13 |
Proprietary Names
P.A.C.E. Depth Gauges
P.A.C.E. Tray for Instruments and Implants
P.A.C.E. Reamer
P.A.C.E. Bending Irons
P.A.C.E. Drill Bit Ao-QC
P.A.C.E and L.I.F.A Cutting Devices
Staple Impactor
Retractors
P.A.C.E Foot and Ankle Plating System Implants and Instruments
P.A.C.E.-DuoFix General Instruments
P.A.C.E. Plating Drill Guides
P.A.C.E.-L.I.F.A.Aiming Devices
P.A.C.E. Plate fixation Olive wire
P.A.C.E. Bending Pins
P.A.C.E. - DuoFix Screwdriver
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)