ORTRON 90* HIP PROSTHESIS

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

CINTOR ORTHOPAEDIC DIV.

The following data is part of a premarket notification filed by Cintor Orthopaedic Div. with the FDA for Ortron 90* Hip Prosthesis.

Pre-market Notification Details

Device IDK802627
510k NumberK802627
Device Name:ORTRON 90* HIP PROSTHESIS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant CINTOR ORTHOPAEDIC DIV. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-23
Decision Date1980-12-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295242338 K802627 000
10603295242321 K802627 000
10603295242307 K802627 000
10603295242246 K802627 000
10603295242208 K802627 000
10603295241904 K802627 000
10603295241898 K802627 000
10603295241881 K802627 000
10603295241874 K802627 000

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