TEMA Elbow System - Line Extension

Prosthesis, Elbow, Semi-constrained, Cemented

LimaCorporate S.p.A.

The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Tema Elbow System - Line Extension.

Pre-market Notification Details

Device IDK222807
510k NumberK222807
Device Name:TEMA Elbow System - Line Extension
ClassificationProsthesis, Elbow, Semi-constrained, Cemented
Applicant LimaCorporate S.p.A. Via Nazionale 52 Villanova Di San Daniele Del Friuli,  IT 33038
ContactMarco Tallerico
CorrespondentKenneth Newman
Lima USA Inc. 2001 NE Green Oaks Blvd. Ste. 100 Arlington,  TX  76006
Product CodeJDB  
CFR Regulation Number888.3160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-16
Decision Date2022-10-26

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