DALL MILES SYSTEM GROOVED BUTTON

Cerclage, Fixation

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Dall Miles System Grooved Button.

Pre-market Notification Details

Device IDK934059
510k NumberK934059
Device Name:DALL MILES SYSTEM GROOVED BUTTON
ClassificationCerclage, Fixation
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactRobert E Smith
CorrespondentRobert E Smith
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-19
Decision Date1994-08-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327036329 K934059 000

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