POROUS TITANIUM ACETABULAR SHELLS

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

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Porous Titanium Acetabular Shells.

Pre-market Notification Details

Device IDK052996
510k NumberK052996
Device Name:POROUS TITANIUM ACETABULAR SHELLS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw,  IN  46581 -0587
ContactAllison Koskey
CorrespondentAllison Koskey
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw,  IN  46581 -0587
Product CodeLPH  
Subsequent Product CodeJDI
Subsequent Product CodeKWZ
Subsequent Product CodeLZO
Subsequent Product CodeMAY
Subsequent Product CodeMEH
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-25
Decision Date2006-04-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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