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Data / Medical devices / Germany / BIEDERMANN MOTECH GMBH & Co. KG

BIEDERMANN MOTECH GMBH & Co. KG: FDA-registered device maker in VS-SCHWENNINGEN Baden-Wurttemberg, Germany, 5 510(k) clearances

BIEDERMANN MOTECH GMBH & Co. KG is registered with the FDA (registration 8010944) in VS-SCHWENNINGEN Baden-Wurttemberg, Germany. It lists 23 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 20, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
8010944
FEI number
3002806545
Address
Berta-Suttner-Strasse 23, VS-SCHWENNINGEN Baden-Wurttemberg, Germany, D-78054
Owner or operator
BIEDERMANN MOTECH GMBH & Co. KG (8010944)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
First device listed
March 12, 1998
Registered through
2026
Brand names listed
JAWS Nitinol Staples, MOSS 100, MOSS Ti Pedicle Screw, MOSS Ti Rod, MOSS VRS, MOSS100 System, Surgical Mesh, TELIX K Implant System

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Manufactureraccessdata.fda.gov
ForcepsHTD1Manufacturer, Specification developeraccessdata.fda.gov
Hammer, SurgicalFZY1Manufacturer, Specification developeraccessdata.fda.gov
Handle, ScalpelGDZ1Manufacturer, Specification developeraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Manufacturer, Specification developeraccessdata.fda.gov
Instrument, CompressionHWN1Manufacturer, Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufacturer, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufacturer, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Manufacturer, Specification developeraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufactureraccessdata.fda.gov
ReamerHTO1Manufacturer, Specification developeraccessdata.fda.gov
RetractorGAD1Manufacturer, Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufactureraccessdata.fda.gov
Screwdriver, SurgicalLRZ1Manufacturer, Specification developeraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Contract manufactureraccessdata.fda.gov
Staple, Fixation, BoneJDR2Contract manufactureraccessdata.fda.gov
Tap, BoneHWX1Manufacturer, Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufacturer, Specification developeraccessdata.fda.gov
Tray, SurgicalLRP1Manufacturer, Specification developeraccessdata.fda.gov
Washer, Bolt NutHTN2Contract manufactureraccessdata.fda.gov
Wrap, SterilizationFRG2Exporter to the USaccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 20, 2021K203607MOSS VRS Spinal SystemNKBSubstantially EquivalentBiedermann Motech GmbH & Co. KGaccessdata.fda.gov
September 13, 2018K181821MOSS VRS Spinal SystemNKBSubstantially EquivalentBiedermann Motech GmbH & Co. KGaccessdata.fda.gov
June 2, 2017K170890TELIX K Interbody SystemMAXSubstantially EquivalentBiedermann Motech GmbH & Co. KGaccessdata.fda.gov
November 17, 2016K162232MOSS 100 Pedicle Screw SystemNKBSubstantially EquivalentBiedermann Motech GmbH & Co. KGaccessdata.fda.gov
February 15, 2006K053389AESCULAP STERILCONTAINER SYSTEMFRGSubstantially EquivalentAesculap, Inc.accessdata.fda.gov

Compare with other makers

Updated August 20, 2021. 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.