TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Trilogy Acetabular System Longevity Crosslinked Polyethylene.

Pre-market Notification Details

Device IDK990135
510k NumberK990135
Device Name:TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactKaren Cain
CorrespondentKaren Cain
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-13
Decision Date1999-07-12
Summary:summary

NIH GUDID Devices

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