SPIN SNAP-OFF 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 Spin Snap-off Screw.

Pre-market Notification Details

Device IDK991477
510k NumberK991477
Device Name:SPIN SNAP-OFF 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 Received1999-04-28
Decision Date1999-07-14
Summary:summary

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