RESORB-X RESORBABLE PLATING SYSTEM

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 Resorbable Plating System.

Pre-market Notification Details

Device IDK011590
510k NumberK011590
Device Name:RESORB-X RESORBABLE PLATING SYSTEM
ClassificationPlate, Bone
Applicant KLS-MARTIN L.P. 962 ALLEGRO LN. Apollo Beach,  FL  33572
ContactArthur Ward
CorrespondentArthur Ward
KLS-MARTIN L.P. 962 ALLEGRO LN. Apollo Beach,  FL  33572
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-23
Decision Date2002-03-20
Summary:summary

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