CONSTRAINED LINER

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

ENCORE MEDICAL, L.P.

The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Constrained Liner.

Pre-market Notification Details

Device IDK023794
510k NumberK023794
Device Name:CONSTRAINED LINER
ClassificationProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Applicant ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin,  TX  78758
ContactDebbie De Los Santos
CorrespondentDebbie De Los Santos
ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin,  TX  78758
Product CodeKWZ  
CFR Regulation Number888.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-13
Decision Date2003-04-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00888912085861 K023794 000
00888912085878 K023794 000
00888912085885 K023794 000
00888912085908 K023794 000
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00888912085694 K023794 000
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00888912085717 K023794 000
00888912085731 K023794 000
00888912085755 K023794 000
00888912085762 K023794 000
00888912085779 K023794 000
00888912085854 K023794 000

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