FDA.report

Vilex LLC

Matched from indexed company URL: VILEX LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
10515261051526Vilex LLC1Y2026-01-01111 MOFFITT ST MCMINNVILLE TN US 37110

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
292961467368025K991197VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24HWC1999-04-26
292961974643727K991151VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREWHWC1999-04-26
292961394607619K973309VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREWHWC1998-01-16
292961395688217K260900DYNEX® External Fixation SystemsKTT2026-04-17
292961656952171K250304TITANEX Screw SystemsHWC2025-03-05
292961045850230K240475Hintermann Series H2 Total Ankle SystemHSN2024-12-02
292961417792358K240035TACTIX Vector Syndesmosis SystemHTN2024-08-01
292961973041925K231504TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemHWC2023-09-11
292961427364310K231493NITINEX Memory Compression StapleJDR2023-08-11
292961840351460K231343Redemption Duo Hindfoot Nail SystemHSB2024-01-30
292961184958472K230462OPTIX H2 Patient Specific Instrument SystemHSN2023-07-17
292961296912204K230204ALPHALOK Plating SystemHRS2023-04-25
292962010334382K221558ALPHALOK Plating SystemHRS2022-11-15
292961324072117K221342REDEMPTION Beaming SystemHWC2022-12-13
292961358827381K202143Dynex MicroKTT2020-09-11
292961505571305K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemKTT2020-08-24
292961492794771K191289Bone Screw Line AdditionHWC2019-07-29
292961378318996K190543Cannulated Hemi ImplantKWD2019-05-31
292961962853333K171004Hintermann Series H2 Total Ankle SystemHSN2017-11-07
292961325045411K151881X-Fix Line AdditionsKTT2016-03-24
292961549792469K151456Small Bone Nail ImplantHSB2015-10-29
292961816872337K150211EzFuze Implant SystemHWC2015-11-10
292962007258117K141937TRIDENT FUSION IMPLANTHWC2014-09-10
292961820894381K132820VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRESJDW2014-07-23
292961352753513K112837VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)JDR2012-10-09
292961965353700K102413FUZE: INTRAMEDULLARY INTERNAL FIXATION NAILHSB2011-11-14
292961563959488K102401HEMI IMPLANT; MINI HEMI IMPLANTKWD2011-07-20
292961138830311K070052MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATIONKWD2007-03-28
292961878775445K052196VILEX X-FIXKTT2005-11-22
292962011474722K041289TALUS OF VILEX (TOV)HWC2004-08-05
292961886960228K041287VILEX BONE PLATE SYSTEMHWC2004-08-05
292961346315243K023684CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365KWD2004-03-01
292961676122003K014154VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00HWC2002-03-18
2929612904097081969-12-31
2929612904097081969-12-31
2929612904097081969-12-31
2929612904097081969-12-31
292961124063870
292961184300715
292961186090316
292961314637962
292961342965586
292961415625926
292961439799800
292961541864059
292961671906670
292961869928639

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HWC122025-03-05
KTT52026-04-17
KWD42019-05-31
HSN32024-12-02
HSB32024-01-30
JDR22023-08-11
HRS22023-04-25
HTN12024-08-01
JDW12014-07-23

PMA

PMN

Applications

GUDID