DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM

Plate, Fixation, Bone

DEROYAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Non-sterile Locking Compression Plate System.

Pre-market Notification Details

Device IDK092317
510k NumberK092317
Device Name:DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM
ClassificationPlate, Fixation, Bone
Applicant DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
ContactGracie Greenway
CorrespondentGracie Greenway
DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-04
Decision Date2009-11-02
Summary:summary

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