GAS PLASMA STERILIZATION

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

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Gas Plasma Sterilization.

Pre-market Notification Details

Device IDK972774
510k NumberK972774
Device Name:GAS PLASMA STERILIZATION
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactRalph H Larsen
CorrespondentRalph H Larsen
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeJWH  
Subsequent Product CodeLPH
Subsequent Product CodeMLR
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-24
Decision Date1999-05-05
Summary:summary

NIH GUDID Devices

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