FDA.reportPublic FDA data

GLW, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30149671493014967149GLW, Inc.1Y2026-01-01930 Sylvan Ave Ste 125 Englewood Cliffs NJ US 07632
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
2214031421367288K223847CREED™ Cannulated ScrewsHWC2023-01-25
3151631421367288K223847CREED™ Cannulated ScrewsHWC2023-01-25
3151631518870198K221489Artemis Proximal Femoral Nail SystemHSB2022-10-27
2214031518870198K221489Artemis Proximal Femoral Nail SystemHSB2022-10-27
2214031450043009K213005Apollo Ankle Fracture Plating SystemHRS2022-03-11
3151631450043009K213005Apollo Ankle Fracture Plating SystemHRS2022-03-11
2214031707265884K201379Artemis Proximal Femoral Nail SystemHSB2021-02-19
3151631145835105K200343FusionFrame Ring Lock SystemKTT2020-09-14
2214031145835105K200343FusionFrame Ring Lock SystemKTT2020-09-14
3151631578825098K200291CREED™ Cannulated ScrewsHWC2020-12-16
2214031578825098K200291CREED™ Cannulated ScrewsHWC2020-12-16
3151631599319479K123234ERMIS STERILIZATION CONTAINER SYSTEMKCT2013-07-05
2214031599319479K123234ERMIS STERILIZATION CONTAINER SYSTEMKCT2013-07-05
2214031303879171K100857FUSION MEDICAL RING LOCK SYSTEMKTT2010-05-27
2214031005055246
3151631005055246
2214031061807666
3151631061807666
2214031070463147
3151631070463147
2214031072022329
3151631072022329
2214031229867797
3151631229867797
2214031294440760
3151631294440760
3151631357653256
2214031357653256
2214031362477744
3151631362477744
2214031415183037
3151631415183037
2214031528224726
3151631528224726
2214031537087393
3151631537087393
2214031547029592
3151631638992569
2214031638992569
3151631859875456
2214031859875456
3151631863894214
2214031863894214
2214031910375812
3151631910375812
3151631965416930
2214031965416930
3151631970472543
2214031970472543

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC42023-01-25
HSB32022-10-27
KTT32020-09-14
HRS22022-03-11
KCT22013-07-05
JDR12023-12-04

PMN#

Applications#

GUDID#

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