COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Compress Segmental Femoral Replacement System.

Pre-market Notification Details

Device IDK043547
510k NumberK043547
Device Name:COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw,  IN  46581 -0587
ContactGary Baker
CorrespondentGary Baker
BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw,  IN  46581 -0587
Product CodeKWA  
Subsequent Product CodeJDI
Subsequent Product CodeJDL
Subsequent Product CodeKRO
Subsequent Product CodeKWY
Subsequent Product CodeKWZ
Subsequent Product CodeLPH
Subsequent Product CodeLZO
Subsequent Product CodeMEH
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-23
Decision Date2005-08-05
Summary:summary

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