Zimmer Biomet Select Ceramic Heads

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

Zimmer, Inc

The following data is part of a premarket notification filed by Zimmer, Inc with the FDA for Zimmer Biomet Select Ceramic Heads.

Pre-market Notification Details

Device IDK181761
510k NumberK181761
Device Name:Zimmer Biomet Select Ceramic Heads
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant Zimmer, Inc PO Box 708 Warsaw,  IN  46581 -0708
ContactCarol Vierling
CorrespondentCarol Vierling
Zimmer, Inc PO Box 708 Warsaw,  IN  46581 -0708
Product CodeLZO  
Subsequent Product CodeKWY
Subsequent Product CodeKWZ
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-03
Decision Date2018-12-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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