4WEB EU B.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
301112759730111275974WEB EU B.V.1N2026-01-01Industrieweg 13b Assendelft Noord-Holland NL 1566JN

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1897831013039760K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)OVE2025-12-11
1897831223300569K252834Sacroiliac Joint Truss System (SJTS)OUR2026-01-28
1897831723286706K251117Cervical Spine Truss System (CSTS)OVE2025-04-25
1897831783986117K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)OVD2024-04-22
1897831285905078K231739Cervical Spine Truss System (CSTS)OVE2023-09-25
1897832001130769K230088Ankle Truss System (ATS)SAI2024-03-21
1897831431301836K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion DeviceOVE2023-02-02
1897832040648047K221283Hammertoe Truss System (HTS)HTY2022-09-06
1897831709629472K221266Cervical Spine Truss System (CSTS) Interbody Fusion DeviceODP2023-01-05
1897831917197440K220463Osteotomy Truss System (OTS)HRS2022-05-18
1897831905380947K212527Cervical Spine Truss System Plating Solution (CSTS-PS)KWQ2022-05-17
1897831522926875K211388Lateral Spine Truss System (LSTS) Interbody Fusion DeviceMAX2021-08-05
1897831049392435K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)KWQ2021-03-10
1897831575105971K200002Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion DeviceOVD2020-05-29
1897831887666220K190926Hammertoe Truss System (HTS)HTY2019-07-23
1897831537820634K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)OVE2019-08-12
1897831482683586K173159Cervical Spinal Truss System (CSTS) Interbody Fusion DeviceODP2018-01-08
1897831066109784K172392Lateral Spinal Truss System (LSTS) Interbody Fusion DeviceMAX2017-11-07
1897831184792260K171351Posterior Spine Truss System (PSTS) Interbody Fusion DeviceMAX2017-09-08
1897831479590196K170851Anterior Spine Truss System (STS) Interbody Fusion DeviceMAX2017-08-07
1897831705507358K153436LATERAL Spine Truss SystemMAX2016-06-06
1897831449717538K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)MAX2015-04-09
1897832052696794K1421124WEB SPINAL IMPLANT PRODUCTSMAX2014-09-23
1897831237933111K1301854WEB OSTEOTOMY BONE WEDGEHRS2013-06-07
1897831158940288K1123164-WEB ALIF SPINAL TRUSS SYSTEM (STS)MAX2011-12-14
1897831018497236K083894ALIF SPINAL TRUSS INTERBODY FUSION DEVICEMAX2011-01-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX92021-08-05
OVE52025-12-11
OVD22024-04-22
ODP22023-01-05
HTY22022-09-06
HRS22022-05-18
KWQ22022-05-17
OUR12026-01-28
SAI12024-03-21