CRAINFIX 2 TITANIUM CLAMP SYSTEM

Plate, Cranioplasty, Preformed, Non-alterable

AESCULAP, INC.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Crainfix 2 Titanium Clamp System.

Pre-market Notification Details

Device IDK122353
510k NumberK122353
Device Name:CRAINFIX 2 TITANIUM CLAMP SYSTEM
ClassificationPlate, Cranioplasty, Preformed, Non-alterable
Applicant AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
ContactDenise Adams
CorrespondentDenise Adams
AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeGXN  
CFR Regulation Number882.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-03
Decision Date2012-08-30
Summary:summary

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