NATURAL-HIP COCR OFFSET STEM

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

SULZER ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Natural-hip Cocr Offset Stem.

Pre-market Notification Details

Device IDK973681
510k NumberK973681
Device Name:NATURAL-HIP COCR OFFSET STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-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 CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-26
Decision Date1997-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024178816 K973681 000
00889024178809 K973681 000
00889024178793 K973681 000

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