AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Amk Total Knee System, Patella Component.

Pre-market Notification Details

Device IDK873197
510k NumberK873197
Device Name:AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
ContactBarry R Sisson
CorrespondentBarry R Sisson
DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-13
Decision Date1987-10-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295039624 K873197 000
10603295039617 K873197 000
10603295039600 K873197 000
10603295039594 K873197 000

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