DEPUY NEUFLEX PIP FINGER

Prosthesis, Finger, Constrained, Polymer

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Neuflex Pip Finger.

Pre-market Notification Details

Device IDK001922
510k NumberK001922
Device Name:DEPUY NEUFLEX PIP FINGER
ClassificationProsthesis, Finger, Constrained, Polymer
Applicant DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw,  IN  46581 -0988
ContactJanet G Johnson
CorrespondentJanet G Johnson
DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw,  IN  46581 -0988
Product CodeKYJ  
CFR Regulation Number888.3230 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-23
Decision Date2000-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295017936 K001922 000
10603295017929 K001922 000
10603295017912 K001922 000
10603295017905 K001922 000
10603295017899 K001922 000

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