CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK)

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 Cruciate Retaining (augmentable) And Constrained Condylar Knee (cck).

Pre-market Notification Details

Device IDK946150
510k NumberK946150
Device Name:CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK)
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactRuth A Wood
CorrespondentRuth A Wood
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-16
Decision Date1995-07-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024224148 K946150 000
00889024224087 K946150 000
00889024224032 K946150 000
00889024224018 K946150 000
00889024223981 K946150 000
00889024223943 K946150 000

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