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Data / Medical devices / Thoracolumbosacral Pedicle Screw System / Germany

FDA-registered makers of Thoracolumbosacral Pedicle Screw System in Germany: 28 establishments

28 establishments in Germany are registered with the FDA to make Thoracolumbosacral Pedicle Screw System (product code NKB). 10 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Thoracolumbosacral Pedicle Screw System
Product code
NKB
Country
Germany

Makers of Thoracolumbosacral Pedicle Screw System in Germany

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer14July 19, 2021000api.fda.gov
BIEDERMANN MOTECH GMBH & Co. KGVS-SCHWENNINGEN Baden-Wurttemberg, GermanyManufacturer, Specification developer3August 20, 2021000api.fda.gov
Signus Medizintechnik GMBHALZENAU Bavaria, GermanyComplaint file establishment, Exporter to the US, Manufacturer, Specification developer3April 13, 2016000api.fda.gov
Joimax GMBHKARLSRUHE Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer2December 18, 2019000api.fda.gov
Kaul Medizintechnik GMBHDierdorf Rhineland-Palatinate, GermanyComplaint file establishment, Foreign private label distributor, Specification developer1April 6, 2021000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer1November 13, 2024000api.fda.gov
Medtronic Sofamor Danek Deggendorf GMBHDEGGENDORF Bavaria, GermanyManufacturer1August 14, 2009000api.fda.gov
Silony Medical GMBHLeinfelden-Echterdingen Baden-Wurttemberg, GermanySpecification developer1January 10, 2018000api.fda.gov
Ulrich GMBH & Co. KGULM Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer1March 4, 2013000api.fda.gov
Z-Medical GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer1February 3, 2015000api.fda.gov
Armbruster GMBHSteinach Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Christian Diener GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Erchinger AGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Eurofins Inpac Medizintechnik GMBHBirkenfeld Baden-Wurttemberg, GermanyContract manufacturer, Contract sterilizer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Friedrich Daniels GMBHSOLINGEN North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Ilg Medizintechnik GMBHDURCHHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
JAKUTEC MEDIZINTECHNIK GMBH & Co. KGLIPTINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medcare Solutions GMBHEmmingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Mediworx.one GMBHSingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Osartis GMBHMuenster Hesse, GermanyManufacturer0000api.fda.gov
Procon Medizintechnik GMBHAlzenau Bavaria, GermanyContract manufacturer0000api.fda.gov
Puracon GMBHRosenheim Bavaria, GermanyContract manufacturer0000api.fda.gov
ProCon Implants GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Rudolf Storz GMBHEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
W+S Solutions GMBHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov

Updated November 2, 2026. 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.