LSF* TOTAL HIP SYSTEM

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

IMPLANT TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Implant Technology, Inc. with the FDA for Lsf* Total Hip System.

Pre-market Notification Details

Device IDK855017
510k NumberK855017
Device Name:LSF* TOTAL HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant IMPLANT TECHNOLOGY, INC. 400 PLAZA DR. Secaucus,  NJ  07094
ContactLaine Mashburn
CorrespondentLaine Mashburn
IMPLANT TECHNOLOGY, INC. 400 PLAZA DR. Secaucus,  NJ  07094
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-16
Decision Date1986-06-11

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