DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE

Plate, Fixation, Bone

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Ace Calcaneal Peri-articular Plate.

Pre-market Notification Details

Device IDK993465
510k NumberK993465
Device Name:DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE
ClassificationPlate, Fixation, Bone
Applicant DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw,  IN  46581 -0988
ContactArlene C Saull
CorrespondentArlene C Saull
DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw,  IN  46581 -0988
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-13
Decision Date2000-01-11
Summary:summary

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