RING-LOK MODULAR BIPOLAR SYSTEM

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

IMPLANTS INTERNATIONAL, LTD

The following data is part of a premarket notification filed by Implants International, Ltd with the FDA for Ring-lok Modular Bipolar System.

Pre-market Notification Details

Device IDK132539
510k NumberK132539
Device Name:RING-LOK MODULAR BIPOLAR SYSTEM
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant IMPLANTS INTERNATIONAL, LTD 4170 BOWMANSROOT COURT Hilliard,  OH  43026
ContactTrudie Seegar, Phd
CorrespondentTrudie Seegar, Phd
IMPLANTS INTERNATIONAL, LTD 4170 BOWMANSROOT COURT Hilliard,  OH  43026
Product CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-13
Decision Date2014-02-07
Summary:summary

NIH GUDID Devices

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