FDA.reportPublic FDA data

3D SYSTEMS - LAYERWISE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
301070500430107050043D SYSTEMS - LAYERWISE1N2026-01-01Grauwmeer 14 Heverlee Vlaams Brabant BE 3001

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1791891494145464K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF CagesMAX2017-07-11
1791891255078388K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyODP2017-07-12
1791891256765332K162264Cascadia Interbody SystemMAX2016-09-21
1791891471299350K160547Cascadia Interbody SystemMAX2016-03-24
1791891891409911K160125Cascadia Interbody SystemODP2016-04-22
1791892052010562K150481Cascadia Interbody SystemMAX2015-08-20
1791891236958546K141405MOBIS II ST SPINAL IMPLANTMAX2014-09-16
1791891154533438K091051BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEMDZE2009-12-08
1791891033165166
1791891034477360
1791891089901533
1791891141746220
1791891154533438
1791891167697046
1791891187622652
1791891236958546
1791891255078388
1791891256765332
1791891289532956
1791891291677264
1791891365122662
1791891446851742
1791891469159556
1791891471299350
1791891494145464
1791891510705757
1791891803212238
1791891817721274
1791891821306785
1791891863779490
1791891871987290
1791891880509759
1791891891409911
1791891901344439
1791891908199880
1791891940000719
1791891965575346
1791891985853521
1791892052010562

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX52017-07-11
ODP22017-07-12
DZE12009-12-08