ANATOMIC MODULAR KNEE (AMK) SYSTEM

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 Anatomic Modular Knee (amk) System.

Pre-market Notification Details

Device IDK864671
510k NumberK864671
Device Name:ANATOMIC MODULAR KNEE (AMK) SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
ContactSteven J Wentworth
CorrespondentSteven J Wentworth
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 Received1986-12-02
Decision Date1987-02-06

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