FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA

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

ENCORE ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation Plasma Sprayed Metal-backed Patella.

Pre-market Notification Details

Device IDK973672
510k NumberK973672
Device Name:FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin,  TX  78758
ContactDebbie De Los Santos
CorrespondentDebbie De Los Santos
ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin,  TX  78758
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-26
Decision Date1997-12-18
Summary:summary

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