Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

Zimmer, Inc.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2mm Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2mm Tibial Recutter.

Pre-market Notification Details

Device IDK200151
510k NumberK200151
Device Name:Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant Zimmer, Inc. 1800 W. Center Street Warsaw,  IN  46580
ContactPankti Shah
CorrespondentPankti Shah
Zimmer, Inc. 1800 W. Center Street Warsaw,  IN  46580
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-22
Decision Date2020-03-17

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