The BioBrace Implant

Mesh, Surgical, Absorbable, Abdominal Hernia

Biorez, Inc.

The following data is part of a premarket notification filed by Biorez, Inc. with the FDA for The Biobrace Implant.

Pre-market Notification Details

Device IDK203267
510k NumberK203267
Device Name:The BioBrace Implant
ClassificationMesh, Surgical, Absorbable, Abdominal Hernia
Applicant Biorez, Inc. 470 James Street, Suite 14 New Haven,  CT  06513
ContactKevin Rocco
CorrespondentRobert A Poggie
BioVera, Inc. 65 Promenade Saint Louis Notre Dame De L'lle Perrot,  CA J7v7p2
Product CodeOWT  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-05
Decision Date2021-04-30

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