PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM

Plate, Fixation, Bone

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Peri-loc Periarticular Locked Plating System.

Pre-market Notification Details

Device IDK092015
510k NumberK092015
Device Name:PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
ClassificationPlate, Fixation, Bone
Applicant SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactDavid Henley
CorrespondentDavid Henley
SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-06
Decision Date2009-07-30
Summary:summary

NIH GUDID Devices

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