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
Phone
810 9827777 ext. 104

Products

Device Name Product Code
Gauge, Depth HTJ
Tray, Surgical, Instrument FSM
Reamer HTO
Bender HXW
Screw, Fixation, Bone HWC
Plate, Fixation, Bone HRS
Bit, Surgical GFG
Bur, Surgical, General & Plastic Surgery GFF
Impactor HWA
Retractor GAD
Orthopedic Manual Surgical Instrument LXH
Instrument, Bending Or Contouring HXP
Screwdriver HXX

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)