OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM

Plate, Cranioplasty, Preformed, Alterable

OSTEOMED L.P.

The following data is part of a premarket notification filed by Osteomed L.p. with the FDA for Osteomed Low Profile Neuro Fixation System.

Pre-market Notification Details

Device IDK111176
510k NumberK111176
Device Name:OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
ClassificationPlate, Cranioplasty, Preformed, Alterable
Applicant OSTEOMED L.P. 3885 ARAPAHO RD. Addison,  TX  75001
ContactPiedad Pena
CorrespondentPiedad Pena
OSTEOMED L.P. 3885 ARAPAHO RD. Addison,  TX  75001
Product CodeGWO  
CFR Regulation Number882.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-27
Decision Date2011-08-15
Summary:summary

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