MAXXOS-MEDICAL GMBH

FDA Device Registration & Listing · Mahlstetten Baden-Wurttemberg, DE · Registration 3011354099

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011354099
FEI Number
3011354099
Entity Name
MAXXOS-MEDICAL GMBH
City/State/Country
Mahlstetten Baden-Wurttemberg, DE
Establishment Address
Kirchbuehlstrasse 6, Mahlstetten Baden-Wurttemberg 78601, DE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
MAXXOS-Medical GmbH (Owner Number: 10059877)
Owner / Operator Contact Address
Kirchbuehlstrasse 6, Mahlstetten, DE-BW 78601, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2025-12-13
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-12-13
HTO Reamer Orthopedic Class 1 888.4540 2025-12-13
HXW Bender Orthopedic Class 1 888.4540 2025-12-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-03-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-03-04
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 2025-12-13
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2025-12-13
HWA Impactor Orthopedic Class 1 888.4540 2025-12-13

Official Correspondent

Patrick Niebel

US Agent Details

Patrick Pringle Business: Biopro Email: pringle@bioproimplants.com Phone: (810) 9827777

Related Public Records

Same Entity

MAXXOS-Medical GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0021-2015 Biomet, Inc. 1
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011354099. Last updated year: 2026. Please use registration number 3011354099 when referencing this establishment in official correspondence.
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