FDA.reportPublic FDA data

Wenzel Spine

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30061725363006172536Wenzel Spine1N2026-01-012535 Brockton Dr Ste 450 Austin TX US 78758

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2830211918368509K250247panaSIa SI Fusion SystemOUR2025-07-09
2830211214771052K231807primaLOK™ SP Interspinous Fusion SystemPEK2023-08-15
2830211383594176K231076VariLift®-C Interbody Fusion SystemODP2023-09-27
2830211351739311K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemMAX2019-01-28
2830211670855334K173247Surgical Planning Software version 1.1LLZ2017-11-08
2830211515090828K172327VMA™ System version 3.0LLZ2017-08-25
2830211983676833K102438PRIMALOK FACET FIXATION SYSTEMMRW2010-09-30
2830211305169931K100820WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEMMAX2010-08-05
2830211613069402K100354PRIMAL OK INTERSPINOUS FUSION SYSTEMKWP2010-08-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX22019-01-28
LLZ22017-11-08
OUR12025-07-09
ODP12023-09-27
PEK12023-08-15
MRW12010-09-30
KWP12010-08-17

PMN#