APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Apr Hip Sys W/cal-coated Can Str Titanium (csti).

Pre-market Notification Details

Device IDK954800
510k NumberK954800
Device Name:APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
ContactBarry J Hassett
CorrespondentBarry J Hassett
INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeMEH  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-27
Decision Date1996-04-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024174221 K954800 000
00889024166790 K954800 000
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00889024174146 K954800 000
00889024174139 K954800 000
00889024174122 K954800 000
00889024643741 K954800 000

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