BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Biolox Delta Ceramic Heads With 100kgy E-poly Acetabular Liners.

Pre-market Notification Details

Device IDK073102
510k NumberK073102
Device Name:BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
ContactBecky Earl
CorrespondentBecky Earl
BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
Product CodeLZO  
Subsequent Product CodeJDI
Subsequent Product CodeLPH
Subsequent Product CodeLWJ
Subsequent Product CodeMAY
Subsequent Product CodeOQG
Subsequent Product CodeOQH
Subsequent Product CodeOQI
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-02
Decision Date2007-11-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05019279316182 K073102 000
00887868248528 K073102 000
00887868248535 K073102 000
00887868248542 K073102 000
00887868248559 K073102 000
05019279316144 K073102 000
05019279316151 K073102 000
05019279316168 K073102 000
05019279316175 K073102 000
00887868248511 K073102 000

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