CONTOUR HA COATED RECONSTRUCTION RING

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Contour Ha Coated Reconstruction Ring.

Pre-market Notification Details

Device IDK040680
510k NumberK040680
Device Name:CONTOUR HA COATED RECONSTRUCTION RING
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova,  TN  38016
ContactJohn Reabe
CorrespondentJohn Reabe
SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova,  TN  38016
Product CodeMEH  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-16
Decision Date2004-06-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885556049242 K040680 000
00885556048771 K040680 000
00885556048610 K040680 000
00885556048528 K040680 000
00885556048207 K040680 000

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