EXTERNAL FIXATION

Pin, Fixation, Threaded

AVANTA ORTHOPAEDICS, INC.

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

Pre-market Notification Details

Device IDK981716
510k NumberK981716
Device Name:EXTERNAL FIXATION
ClassificationPin, Fixation, Threaded
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 CodeJDW  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-15
Decision Date1998-07-17
Summary:summary

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