TECHFIT Patient-Specific Maxillofacial System

Plate, Bone

Industrias Medicas Sampedro S.A.S.

The following data is part of a premarket notification filed by Industrias Medicas Sampedro S.a.s. with the FDA for Techfit Patient-specific Maxillofacial System.

Pre-market Notification Details

Device IDK203282
510k NumberK203282
Device Name:TECHFIT Patient-Specific Maxillofacial System
ClassificationPlate, Bone
Applicant Industrias Medicas Sampedro S.A.S. Carrera 47 N 100 Sur 40 Centro Industrial Portal Del Sur Bodega 14 La Estrella,  CO 055468
ContactLeidy Johanna Toro Gonzalez
CorrespondentLeidy Johanna Toro Gonzalez
Industrias Medicas Sampedro S.A.S. Carrera 47 N 100 Sur 40 Centro Industrial Portal Del Sur Bodega 14 La Estrella,  CO 055468
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-06
Decision Date2021-05-19

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