MONOTUBE EXTERNAL FIXATION SYSTEM

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Monotube External Fixation System.

Pre-market Notification Details

Device IDK910483
510k NumberK910483
Device Name:MONOTUBE EXTERNAL FIXATION SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactRobert E Smith
CorrespondentRobert E Smith
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-06
Decision Date1992-07-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327072839 K910483 000
07613327072822 K910483 000
07613327072785 K910483 000

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