INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS

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

SULZER ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Inter-op Durasul Acetabular Inserts/cocr Femoral Heads.

Pre-market Notification Details

Device IDK993259
510k NumberK993259
Device Name:INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin,  TX  78717
ContactMitchell A Dhority
CorrespondentMitchell A Dhority
SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-29
Decision Date2000-03-10
Summary:summary

NIH GUDID Devices

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