NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural-hip System Porous Stem With Ha/csti.

Pre-market Notification Details

Device IDK970300
510k NumberK970300
Device Name:NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
ContactLori Kleinschridt Holder
CorrespondentLori Kleinschridt Holder
INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-24
Decision Date1997-07-03
Summary:summary

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