RESORB-X G

Plate, Cranioplasty, Preformed, Alterable

KLS-MARTIN L.P.

The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Resorb-x G.

Pre-market Notification Details

Device IDK121606
510k NumberK121606
Device Name:RESORB-X G
ClassificationPlate, Cranioplasty, Preformed, Alterable
Applicant KLS-MARTIN L.P. 11201 SAINT JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville,  FL  32246
ContactJennifer Damato
CorrespondentJennifer Damato
KLS-MARTIN L.P. 11201 SAINT JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville,  FL  32246
Product CodeGWO  
CFR Regulation Number882.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-01
Decision Date2013-01-17
Summary:summary

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