MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM

Plate, Bone

BIOPLATE, INC.

The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for Modification To Bioplate Bioclip Craniotomy Fixation System.

Pre-market Notification Details

Device IDK002879
510k NumberK002879
Device Name:MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
ClassificationPlate, Bone
Applicant BIOPLATE, INC. 6911 MELROSE AVE. Los Angeles,  CA  90038
ContactEric V Hohenstein
CorrespondentEric V Hohenstein
BIOPLATE, INC. 6911 MELROSE AVE. Los Angeles,  CA  90038
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-15
Decision Date2000-10-05

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