NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural-hip(tm) System - Calcar Replcement Stem.

Pre-market Notification Details

Device IDK945516
510k NumberK945516
Device Name:NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactJoann Ringer-kuhne
CorrespondentJoann Ringer-kuhne
INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-09
Decision Date1995-02-14

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