Zimmer Biomet 12/14 CoCr Femoral Head And Freedom Head

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

Zimmer, Inc.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Biomet 12/14 Cocr Femoral Head And Freedom Head.

Pre-market Notification Details

Device IDK183457
501k NumberK183457
Device Name:Zimmer Biomet 12/14 CoCr Femoral Head And Freedom Head
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant Zimmer, Inc. P.O. Box 708 Warsaw,  IN  46581 -0708
ContactRebecca Nofiz
CorrespondentDean Heit
ZimmerBiomet Waterton Ind Estate Bridgend,  GB Cf31 3xa
Product CodeLPH  
Subsequent Product CodeJDI
Subsequent Product CodeKWZ
Subsequent Product CodeLZO
Subsequent Product CodeOQG
Subsequent Product CodeOQH
Subsequent Product CodeOQI
Subsequent Product CodePBI
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-13
Decision Date2019-11-05

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