DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM

Plate, Fixation, Bone

AVANTA ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Avanta Orthopaedics, Inc. with the FDA for Distal Radius Fracture Fixation Plate System.

Pre-market Notification Details

Device IDK990596
510k NumberK990596
Device Name:DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
ClassificationPlate, Fixation, Bone
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 CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-24
Decision Date1999-04-29
Summary:summary

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