IOI 32 TM FEMORAL COMPONENT

Prosthesis, Hip, Hemi-, Femoral, Metal

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Ioi 32 Tm Femoral Component.

Pre-market Notification Details

Device IDK822321
510k NumberK822321
Device Name:IOI 32 TM FEMORAL COMPONENT
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal
Applicant INTERMEDICS ORTHOPEDICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKWL  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-03
Decision Date1982-08-20

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