NEWDEAL ANKLE NAIL

Rod, Fixation, Intramedullary And Accessories

NEWDEAL S.A.

The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Newdeal Ankle Nail.

Pre-market Notification Details

Device IDK050882
510k NumberK050882
Device Name:NEWDEAL ANKLE NAIL
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant NEWDEAL S.A. 311 ENTERPRISE DRIVE Plainsboro,  NJ  08536
ContactJudith E O'grady
CorrespondentJudith E O'grady
NEWDEAL S.A. 311 ENTERPRISE DRIVE Plainsboro,  NJ  08536
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-07
Decision Date2005-05-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780044482 K050882 000
10381780044567 K050882 000
M248500350ND1 K050882 000
10381780044543 K050882 000
M248500250ND1 K050882 000
M248500180ND1 K050882 000
M248500150ND1 K050882 000
10381780125860 K050882 000

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