Porous Patella

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

Encore Medical, L.P. Dba DJO Surgical

The following data is part of a premarket notification filed by Encore Medical, L.p. Dba Djo Surgical with the FDA for Porous Patella.

Pre-market Notification Details

Device IDK212941
510k NumberK212941
Device Name:Porous Patella
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant Encore Medical, L.P. Dba DJO Surgical 9800 Metric Boulevard Austin,  TX  78758
ContactMichael A Siano
CorrespondentMichael A Siano
Encore Medical, L.P. Dba DJO Surgical 9800 Metric Boulevard Austin,  TX  78758
Product CodeMBH  
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-15
Decision Date2022-01-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00190446365914 K212941 000
00190446365907 K212941 000
00190446365891 K212941 000
00190446337430 K212941 000
00190446337423 K212941 000
00190446337416 K212941 000
00190446337409 K212941 000
00190446337393 K212941 000
00190446238843 K212941 000

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