MODIFICATION TO THE I.C.O.S SCREW

Screw, Fixation, Bone

NEWDEAL S.A.

The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Modification To The I.c.o.s Screw.

Pre-market Notification Details

Device IDK011821
510k NumberK011821
Device Name:MODIFICATION TO THE I.C.O.S SCREW
ClassificationScrew, Fixation, Bone
Applicant NEWDEAL S.A. 9109 COPENHAVER DR. Potomac,  MD  20854
ContactNorman F Estrin
CorrespondentNorman F Estrin
NEWDEAL S.A. 9109 COPENHAVER DR. Potomac,  MD  20854
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-11
Decision Date2001-09-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780064428 K011821 000
10381780064411 K011821 000

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