AMF Revision TT Cones

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 Amf Revision Tt Cones.

Pre-market Notification Details

Device IDK200653
510k NumberK200653
Device Name:AMF Revision TT Cones
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
ContactRoberto Gabetta
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 Received2020-03-12
Decision Date2020-05-07

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.