VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS

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 Versys Fiber Metal Midcoat Low Head Center Hip Prosthesis.

Pre-market Notification Details

Device IDK061786
510k NumberK061786
Device Name:VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactPatricia Jenks
CorrespondentPatricia Jenks
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-26
Decision Date2006-07-24
Summary:summary

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