Signature Orthopaedics Pty, Ltd. - FDA 510(k) Cleared Devices
44
Total
44
Cleared
0
Denied
44 devices
Cleared
Jun 19, 2020
Cemented TSI Hip Stem
Orthopedic
326d
Cleared
Nov 27, 2019
World Knee Total Knee Systems
Orthopedic
266d
Cleared
Aug 28, 2019
Signature Ceramic Femoral Head
Orthopedic
163d
Cleared
Feb 11, 2019
Cemented TSI Hip Stem
Orthopedic
266d
Cleared
Jan 17, 2019
Pinehurst Anterior Cervical Plate System
Orthopedic
258d
Cleared
Jan 17, 2019
Imboki Knee Instrument System
Orthopedic
241d
Cleared
Dec 07, 2018
C-Zero Pedicle Screw System, Freedom Pedicle Screw System
Orthopedic
260d
Cleared
Oct 24, 2018
World Total Knee System
Orthopedic
135d
Cleared
Apr 20, 2018
World Knee System
Orthopedic
29d
Cleared
Jan 29, 2018
40-42mm BiPolar Head and 22mm Femoral Head
Orthopedic
452d
Cleared
Nov 29, 2017
Brisbane ALIF Device, Gladstone ALIF Device
Orthopedic
147d
Cleared
Nov 29, 2017
Arlington PLIF/TLIF Cage
Orthopedic
147d
Cleared
Aug 11, 2017
NOOSA Anterior Lumbar Plate System
Orthopedic
232d
Cleared
Jul 17, 2017
Genius Total Knee System
Orthopedic
138d
Cleared
Sep 06, 2016
Active-X Total Knee System
Orthopedic
223d
Cleared
Jul 19, 2016
Origin Coxa Vara Hip Stem
Orthopedic
85d
Cleared
Jun 03, 2016
Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical...
Orthopedic
217d
Cleared
Mar 17, 2015
Evolve UniPolar Head
Orthopedic
132d
Cleared
Dec 28, 2012
ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL...
Orthopedic
242d