Biolox Delta Ceramic Heads, Biolox Delta Option Ceramic Heads

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

Biomet UK Ltd.

The following data is part of a premarket notification filed by Biomet Uk Ltd. with the FDA for Biolox Delta Ceramic Heads, Biolox Delta Option Ceramic Heads.

Pre-market Notification Details

Device IDK192683
510k NumberK192683
Device Name:Biolox Delta Ceramic Heads, Biolox Delta Option Ceramic Heads
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant Biomet UK Ltd. Waterton Industrial Estate Bridgend,  GB Cf31 3xa
ContactLisa Ingram
CorrespondentLisa Ingram
Biomet UK Ltd. Waterton Industrial Estate Bridgend,  GB Cf31 3xa
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)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-26
Decision Date2020-02-27

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