TSX Implants

Implant, Endosseous, Root-form

Biomet 3i LLC

The following data is part of a premarket notification filed by Biomet 3i Llc with the FDA for Tsx Implants.

Pre-market Notification Details

Device IDK220978
510k NumberK220978
Device Name:TSX Implants
ClassificationImplant, Endosseous, Root-form
Applicant Biomet 3i LLC 4555 Riverside Drive Palm Beach Gardens,  FL  33410
ContactMariela Cabarcas
CorrespondentMariela Cabarcas
Biomet 3i LLC 4555 Riverside Drive Palm Beach Gardens,  FL  33410
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-04
Decision Date2022-09-14

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