RADIAL HEAD IMPLANT

Prosthesis, Elbow, Hemi-, Radial, Polymer

AVANTA ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Avanta Orthopaedics, Inc. with the FDA for Radial Head Implant.

Pre-market Notification Details

Device IDK011819
510k NumberK011819
Device Name:RADIAL HEAD IMPLANT
ClassificationProsthesis, Elbow, Hemi-, Radial, Polymer
Applicant AVANTA ORTHOPAEDICS, INC. 9369 CARROLL PARK DRIVE, STE.A San Diego,  CA  92121
ContactLouise M Focht
CorrespondentLouise M Focht
AVANTA ORTHOPAEDICS, INC. 9369 CARROLL PARK DRIVE, STE.A San Diego,  CA  92121
Product CodeKWI  
CFR Regulation Number888.3170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-11
Decision Date2001-06-19
Summary:summary

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