CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK

Cerclage, Fixation

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Cable-ease Plate And Cable System - Trochanteric Hook.

Pre-market Notification Details

Device IDK950027
510k NumberK950027
Device Name:CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK
ClassificationCerclage, Fixation
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactBarry J Hassett
CorrespondentBarry J Hassett
INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-04
Decision Date1995-03-06

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