Data / Medical devices / Germany / Maxxos-Medical GMBH
Maxxos-Medical GMBH: FDA-registered device maker in Mahlstetten Baden-Wurttemberg, Germany, 1 510(k) clearance
Maxxos-Medical GMBH is registered with the FDA (registration 3011354099) in Mahlstetten Baden-Wurttemberg, Germany. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 8, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011354099
- Address
- Kirchbuehlstrasse 6, Mahlstetten Baden-Wurttemberg, Germany, 78601
- Owner or operator
- MAXXOS-Medical GmbH (10059877)
- Roles
- Complaint file establishment, Contract manufacturer, Specification developer
- First device listed
- March 4, 2019
- Registered through
- 2026
- Brand names listed
- P.A.C.E Foot and Ankle Plating System Implants and Instruments, P.A.C.E and L.I.F.A Cutting Devices, P.A.C.E. - DuoFix Screwdriver, P.A.C.E. Bending Irons, P.A.C.E. Bending Pins, P.A.C.E. Depth Gauges, P.A.C.E. Drill Bit Ao-QC, P.A.C.E. Plate fixation Olive wire and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bender | HXW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bit, Surgical | GFG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bur, Surgical, General & Plastic Surgery | GFF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Contract manufacturer, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Contract manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2025 | K251892 | MAXXOS P.A.C.E. Foot & Ankle Plating System | HRS | Substantially Equivalent | Maxxos Medical GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Bending Or Contouring
- All makers of Gauge, Depth
- All makers of Tray, Surgical, Instrument
- All makers of Reamer
- All makers of Retractor
- All makers of Screw, Fixation, Bone
Updated September 8, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.