DEPUY ORTHOTECH SPIKED WASHER

Washer, Bolt Nut

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Orthotech Spiked Washer.

Pre-market Notification Details

Device IDK983906
510k NumberK983906
Device Name:DEPUY ORTHOTECH SPIKED WASHER
ClassificationWasher, Bolt Nut
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactSally Foust
CorrespondentSally Foust
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-03
Decision Date1998-12-18
Summary:summary

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