3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS

Plate, Bone

IMPLANT INNOVATIONS, INC.

The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for 3i Oral/maxillofacial Bone Fixation System: Cocrmo Alloy (vitalium) Bone-mesh/plate & Screws.

Pre-market Notification Details

Device IDK952812
510k NumberK952812
Device Name:3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS
ClassificationPlate, Bone
Applicant IMPLANT INNOVATIONS, INC. 3071 CONTINENTAL DR. West Palm Beach,  FL  33407
ContactWilliam G Conety
CorrespondentWilliam G Conety
IMPLANT INNOVATIONS, INC. 3071 CONTINENTAL DR. West Palm Beach,  FL  33407
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-19
Decision Date1995-08-30

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