KLS-MARTIN ORTHO ANCHORAGE SYSTEM

Implant, Endosseous, Root-form

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 Ortho Anchorage System.

Pre-market Notification Details

Device IDK033483
510k NumberK033483
Device Name:KLS-MARTIN ORTHO ANCHORAGE SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville,  FL  32246
ContactJennifer Damato
CorrespondentJennifer Damato
KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville,  FL  32246
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-11-04
Decision Date2004-01-15
Summary:summary

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