TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM

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

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Taperloc Femoral Stem And Universal Acetabular Com.

Pre-market Notification Details

Device IDK921301
510k NumberK921301
Device Name:TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw,  IN  46581 -0587
ContactPatricia S Beres
CorrespondentPatricia S Beres
BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw,  IN  46581 -0587
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-18
Decision Date1994-02-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304553927 K921301 000
00880304553910 K921301 000

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