NATURAL POROUS HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural Porous Hip System.

Pre-market Notification Details

Device IDK913060
510k NumberK913060
Device Name:NATURAL POROUS HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactWebb
CorrespondentWebb
INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-10
Decision Date1991-10-11

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