BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

Plate, Cranioplasty, Preformed, Non-alterable

BIOPLATE, INC.

The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for Bioplate Rigid Bone Plating System For Craniomaxillofacial Surgery.

Pre-market Notification Details

Device IDK062819
510k NumberK062819
Device Name:BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
ClassificationPlate, Cranioplasty, Preformed, Non-alterable
Applicant BIOPLATE, INC. 3643 LENAWEE AVE. Los Angeles,  CA  90016 -4310
ContactJesus T Farinas
CorrespondentJesus T Farinas
BIOPLATE, INC. 3643 LENAWEE AVE. Los Angeles,  CA  90016 -4310
Product CodeGXN  
CFR Regulation Number882.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-20
Decision Date2006-12-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M384815791US0 K062819 000
M384815791CP0 K062819 000
M3848157910 K062819 000

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