RESORB X-G

Plate, Bone

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 IDK112064
510k NumberK112064
Device Name:RESORB X-G
ClassificationPlate, Bone
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 CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-19
Decision Date2012-03-23
Summary:summary

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