FDA.reportPublic FDA data

GLW Europe GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30265932333026593233GLW Europe GmbH1N2026-01-01Max-Planck-Str.12 Wurmlingen Baden-Wurttemberg DE 78573

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3151631571435200K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR2023-12-04
3151631421367288K223847CREED™ Cannulated ScrewsHWC2023-01-25
3151631518870198K221489Artemis Proximal Femoral Nail SystemHSB2022-10-27
3151631450043009K213005Apollo Ankle Fracture Plating SystemHRS2022-03-11
3151631145835105K200343FusionFrame Ring Lock SystemKTT2020-09-14
3151631578825098K200291CREED™ Cannulated ScrewsHWC2020-12-16
3151631599319479K123234ERMIS STERILIZATION CONTAINER SYSTEMKCT2013-07-05
3151631005055246
3151631061807666
3151631070463147
3151631072022329
3151631229867797
3151631294440760
3151631357653256
3151631362477744
3151631415183037
3151631528224726
3151631537087393
3151631638992569
3151631859875456
3151631863894214
3151631910375812
3151631965416930
3151631970472543

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC22023-01-25
JDR12023-12-04
HSB12022-10-27
HRS12022-03-11
KTT12020-09-14
KCT12013-07-05