DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS

Prosthesis, Finger, Constrained, Polymer

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Dupont Orthopaedics Finger Joint Prosthesis.

Pre-market Notification Details

Device IDK970544
510k NumberK970544
Device Name:DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS
ClassificationProsthesis, Finger, Constrained, Polymer
Applicant DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
ContactCherly Hastings
CorrespondentCherly Hastings
DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
Product CodeKYJ  
CFR Regulation Number888.3230 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-12
Decision Date1997-09-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295017950 K970544 000
10603295018001 K970544 000
10603295017998 K970544 000
10603295017981 K970544 000
10603295017974 K970544 000
10603295017967 K970544 000
10603295017943 K970544 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.