THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

Plate, Bone

BIOMEDICS

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

Pre-market Notification Details

Device IDK992330
510k NumberK992330
Device Name:THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
ClassificationPlate, Bone
Applicant BIOMEDICS 6911 MELROSE AVE. Los Angeles,  CA  90038
ContactEric V Hohenstein
CorrespondentEric V Hohenstein
BIOMEDICS 6911 MELROSE AVE. Los Angeles,  CA  90038
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-12
Decision Date1999-11-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M384P2SK06330 K992330 000
M3848133501 K992330 000
M3848133071 K992330 000
M3848133031 K992330 000
M3848131500 K992330 000
M3848131490 K992330 000
M384813148US0 K992330 000
M3848131480 K992330 000
M3848131471 K992330 000
M3848131460 K992330 000
M3848131450 K992330 000
M384813144US0 K992330 000
M3848131440 K992330 000
M3848133511 K992330 000
M3848133520 K992330 000
M384P2SK04230 K992330 000
M384P2SK0214051 K992330 000
M384P2SK02140 K992330 000
M384P2CK06320 K992330 000
M384P2CK04220 K992330 000
M3848133730 K992330 000
M3848133720 K992330 000
M3848133710 K992330 000
M3848133700 K992330 000
M3848133560 K992330 000
M3848133550 K992330 000
M3848133540 K992330 000
M3848131431 K992330 000

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