DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile

Plate, Fixation, Bone

Synthes (USA) Products LLC

The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Depuy Synthes 2.4mm Lcp Straight Wrist Plate, Sterile.

Pre-market Notification Details

Device IDK192327
501k NumberK192327
Device Name:DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile
ClassificationPlate, Fixation, Bone
Applicant Synthes (USA) Products LLC 1301 Goshen Parkway West Chester,  PA  19380
ContactThomas Shea
CorrespondentThomas Shea
Synthes (USA) Products LLC 1301 Goshen Parkway West Chester,  PA  19380
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-27
Decision Date2019-11-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886982291226 K192327 000

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