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Orthosensor, Inc.

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
8
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0087-2019Class IIOrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.July 12, 2018
Z-0086-2019Class IIOrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.July 12, 2018
Z-0082-2019Class IIOrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.July 12, 2018
Z-0084-2019Class IIOrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.July 12, 2018
Z-0083-2019Class IIOrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.July 12, 2018
Z-0085-2019Class IIOrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.July 12, 2018
Z-1029-2015Class IIVerasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamiDecember 5, 2014
Z-0122-2013Class II"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***SFebruary 4, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation August 25, 2020
K200665VERASENSE for Stryker TriathlonApril 12, 2020
K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 April 1, 2020
K180459VERASENSE for Zimmer Biomet PersonaJune 7, 2018
K150372VERASENSE Knee SystemApril 15, 2016
K131767ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEMNovember 8, 2013
K130380ORTHOSENSOR KNEE BALANCERJune 13, 2013
K090474ORTHOREX INTRA-OPERATIVE LOAD SENSOROctober 19, 2009