INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)

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 Ha Porous Acetabular System (ha/csti).

Pre-market Notification Details

Device IDK972393
510k NumberK972393
Device Name:INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin,  TX  78717
ContactJacquelyn Hughes
CorrespondentJacquelyn Hughes
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 Received1997-06-26
Decision Date1997-09-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024181939 K972393 000
00889024181922 K972393 000
00889024181915 K972393 000

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