OSTEOMED CRANIAL FLAP FIXATION SYSTEM

Plate, Cranioplasty, Preformed, Non-alterable

OSTEOMED CORP.

The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Cranial Flap Fixation System.

Pre-market Notification Details

Device IDK022277
510k NumberK022277
Device Name:OSTEOMED CRANIAL FLAP FIXATION SYSTEM
ClassificationPlate, Cranioplasty, Preformed, Non-alterable
Applicant OSTEOMED CORP. 3750 REALTY RD. Addison,  TX  75001 -4311
ContactDawn T Holdeman
CorrespondentDawn T Holdeman
OSTEOMED CORP. 3750 REALTY RD. Addison,  TX  75001 -4311
Product CodeGXN  
CFR Regulation Number882.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-15
Decision Date2003-04-01
Summary:summary

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