MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM

Plate, Bone

BIOPLATE, INC.

The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for Modified Sterile Plate & Screw Kit Configurations For Use With Bioplate Titanium Fixation System.

Pre-market Notification Details

Device IDK082757
510k NumberK082757
Device Name:MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM
ClassificationPlate, Bone
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 CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-19
Decision Date2008-10-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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