ClearanceBrief
510(k) K180459 ยท ONN Intraoperative Orthopedic Joint Assessment Aid

VERASENSE for Zimmer Biomet Persona

ApplicantOrthosensor, Inc., Dania Beach FL, US
DecisionSubstantially Equivalent, Jun 7, 2018
ReceivedFeb 20, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K180459

DateFirm and productCodeLinked 510(k)
Jul 12, 2018Orthosensor, Inc.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
Terminated		 ONNNone listed
Jul 12, 2018Orthosensor, Inc.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.
Terminated		 ONNNone listed
Jul 12, 2018Orthosensor, Inc.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.
Terminated		 ONNNone listed
Jul 12, 2018Orthosensor, Inc.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
Terminated		 ONNNone listed
Jul 12, 2018Orthosensor, Inc.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.
Terminated		 ONNNone listed
Jul 12, 2018Orthosensor, Inc.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
Terminated		 ONNNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.