Signature Orthopaedics Europe L T D

FDA Filings

This page includes the latest FDA filings for Signature Orthopaedics Europe L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3014763043
FEI Number3014763043
NameSignature Orthopaedics Europe Ltd
Owner & OperatorSignature Orthopaedics Pty Limited
Contact Address7 Sirius Road
Lane Cove West AU-NSW New South Wales 2066 AU
Official Correspondent
  • Declan P Brazil
  • 61-02-94115514-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressUnit A, IDA Business & Technology Park, Garrycastle
Athlone Westmeath, N37 DY26 IE
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device
Company
DeviceDate
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
World Total Knee System2019-12-16
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
World Total Knee System2019-12-16
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Femoral Head2018-04-25
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
BiPolar Head2018-04-25
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Retractor2017-10-09
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
PureGenius Total Knee System2017-07-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Genius Total Knee Trial Instruments2017-07-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Genius Total Knee System2017-07-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Crescendo Total Knee System2017-07-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Dymaxeon Spine System2016-09-13
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Dymaxeon Spine System2016-09-13
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Dymaxeon Spine System2016-09-13
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Dymaxeon Spine System2016-09-13
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Dymaxeon Spine System2016-09-13
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Dymaxeon Spine System2016-09-13
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Active-X Ultracongruent+ Meniscal Insert2016-09-07
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Active-X Ultracongruent Meniscal Insert2016-09-07
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Active-X Regular Meniscal Insert2016-09-07
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Active-X Patella Component2016-09-07
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Active-X Inlay Patella Component2016-09-07
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Active-X Cemented Tibial Component2016-09-07
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Active-X Cemented Femoral Component2016-09-07
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Active-X Ultracongruent+ Meniscal Insert2016-09-07
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Active-X Ultracongruent Meniscal Insert2016-09-07
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Active-X Regular Meniscal Insert2016-09-07
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Active-X Patella Component2016-09-07
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Active-X Inlay Patella Component2016-09-07
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Active-X Cemented Tibial Component2016-09-07
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Active-X Cemented Femoral Component2016-09-07
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Origin Lateral Offset Collared Hip Stem2016-07-27
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Origin Coxa Vara Stem2016-07-27
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Origin Lateral Offset Collared Hip Stem2016-07-27
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Origin Coxa Vara Stem2016-07-27
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Manza Shell2016-06-05
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical Constrained Liner2016-06-05
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical C-Series Shell2016-06-05
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical 20deg Hooded Liner2016-06-05
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Manza Shell2016-06-05
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical Constrained Liner2016-06-05
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical C-Series Shell2016-06-05
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical 20deg Hooded Liner2016-06-05
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Manza Shell2016-06-05
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical Constrained Liner2016-06-05
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical C-Series Shell2016-06-05
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical 20deg Hooded Liner2016-06-05
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
SKYLON Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Remedy Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Pelion Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Pegasus Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Evolve Masters Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Evolve Helios Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Encina Taper A2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Distal Centraliser2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Cement Plug2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Bipolar Head2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
SKYLON Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Remedy Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Pelion Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Pegasus Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Evolve Masters Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Evolve Helios Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Encina Taper A2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Distal Centraliser2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Cement Plug2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Bipolar Head2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
SKYLON Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Remedy Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Pelion Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Pegasus Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Evolve Masters Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Evolve Helios Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Encina Taper A2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Distal Centraliser2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Cement Plug2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Bipolar Head2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
SKYLON Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Remedy Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Pelion Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Pegasus Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Evolve Masters Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Evolve Helios Stem2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Encina Taper A2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Distal Centraliser2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Cement Plug2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Bipolar Head2014-08-11
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Vento Cup2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Tryon Liner2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Tryon Acetabular Cup2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Stratus Stem2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Sirocco Stem2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Origin Stem2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
NEO-T Stem2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Manza Screws2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Manza Polyethylene Liner2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Manza Hole Cover2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Manza Heads2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical PX Series2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical Hole Cover2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical G Series2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical Bone Screw2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical Acetabular Liner2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Kratos Stem2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Fixation Screw2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Femoral Head2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Encina Taper Femoral Stem Standard Offset2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Encina Taper Femoral Stem High Offset2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Encina HA Femoral Stem Standard Offset2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Encina HA Femoral Stem Standard Offset Collared2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Encina HA Femoral Stem High Offset2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Cup Apex Hole Cover2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
CoCr Head2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
BIOLOX Forte2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
BIOLOX Delta2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Aria Stem2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Vento Cup2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Tryon Liner2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Tryon Acetabular Cup2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Stratus Stem2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Sirocco Stem2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Origin Stem2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
NEO-T Stem2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Manza Screws2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Manza Polyethylene Liner2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Manza Hole Cover2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Manza Heads2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical PX Series2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical Hole Cover2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical G Series2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical Bone Screw2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Logical Acetabular Liner2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Kratos Stem2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Fixation Screw2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Femoral Head2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Encina Taper Femoral Stem Standard Offset2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Encina Taper Femoral Stem High Offset2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Encina HA Femoral Stem Standard Offset2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Encina HA Femoral Stem Standard Offset Collared2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Encina HA Femoral Stem High Offset2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Cup Apex Hole Cover2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
CoCr Head2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
BIOLOX Forte2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
BIOLOX Delta2013-01-17
Signature Orthopaedics Europe Ltd [Signature Orthopaedics Pty Limited]
Aria Stem2013-01-17

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