KLS Martin IPS Preprosthetic

Implant, Subperiosteal

KLS-Martin L.P.

The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Kls Martin Ips Preprosthetic.

Pre-market Notification Details

Device IDK210228
510k NumberK210228
Device Name:KLS Martin IPS Preprosthetic
ClassificationImplant, Subperiosteal
Applicant KLS-Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville,  FL  32246
ContactJennifer Damato
CorrespondentSusan Leander
KLS Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville,  FL  32246
Product CodeELE  
CFR Regulation Number872.3645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-28
Decision Date2022-07-08

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