BIEDERMANN MOTECH GMBH & Co. KG

FDA Device Registration & Listing · VS-SCHWENNINGEN Baden-Wurttemberg, DE · Registration 8010944

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
8010944
FEI Number
3002806545
Entity Name
BIEDERMANN MOTECH GMBH & Co. KG
City/State/Country
VS-SCHWENNINGEN Baden-Wurttemberg, DE
Establishment Address
BERTA-SUTTNER-STRASSE 23, VS-SCHWENNINGEN Baden-Wurttemberg D-78054, DE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
BIEDERMANN MOTECH GMBH & Co. KG (Owner Number: 8010944)
Owner / Operator Contact Address
BERTHA-VON-SUTTNER-STRASSE 23, --, VILLINGEN-SCHWENNINGEN, DE-BW D-78054, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

JAWS Nitinol Staples Surgical Mesh MOSS 100 MOSS Ti Pedicle Screw MOSS Ti Rod MOSS Ti Rod MOSS Ti Pedicle Screw MOSS VRS TELIX K Implant System MOSS100 System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-12-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-10-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-10-14
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2017-07-26
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2016-12-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-10-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-10-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2007-11-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-12-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-12-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-12-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-11-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-11-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-09-19
HTO Reamer Orthopedic Class 1 888.4540 2016-12-22
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2016-12-22
LRZ Screwdriver, Surgical General, Plastic Surgery Class 1 878.4800 2016-12-22
HTD Forceps General, Plastic Surgery Class 1 878.4800 2016-12-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-08-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-08-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-03-20
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2020-04-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-06-09
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2016-12-22

Official Correspondent

Gerd Federle

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

BIEDERMANN MOTECH GMBH & Co. KG
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-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
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM 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-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010944. Last updated year: 2026. Please use registration number 8010944 when referencing this establishment in official correspondence.
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