Internal Distraction - Sterile

Cranial Distraction System

KLS Martin LP

The following data is part of a premarket notification filed by Kls Martin Lp with the FDA for Internal Distraction - Sterile.

Pre-market Notification Details

Device IDK163315
510k NumberK163315
Device Name:Internal Distraction - Sterile
ClassificationCranial Distraction System
Applicant KLS Martin LP 11201 Saint Johns Industrial Pkwy S Jacksonville,  FL  32246
ContactJennifer Damato
CorrespondentJennifer Damato
KLS Martin LP 11201 Saint Johns Industrial Pkwy S Jacksonville,  FL  32246
Product CodePBJ  
CFR Regulation Number882.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-23
Decision Date2017-05-05
Summary:summary

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