Physica System

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

LimaCorporate S.p.A

The following data is part of a premarket notification filed by Limacorporate S.p.a with the FDA for Physica System.

Pre-market Notification Details

Device IDK213381
510k NumberK213381
Device Name:Physica System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant LimaCorporate S.p.A Via Nazionale 52 Villanova Di San Daniele Del Friuli,  IT 33038
ContactIlaria Giannuzzi
CorrespondentLacey Harbour
Lima USA Inc. 2001 NE Green Oaks Blvd. Ste. 100 Arlington,  TX  76006
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-13
Decision Date2021-12-17

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