VERSAFITCUP CC TRIO-ADDITIONAL LINERS

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

MEDACTA INTERNATIONAL

The following data is part of a premarket notification filed by Medacta International with the FDA for Versafitcup Cc Trio-additional Liners.

Pre-market Notification Details

Device IDK120531
510k NumberK120531
Device Name:VERSAFITCUP CC TRIO-ADDITIONAL LINERS
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo,  CA  93012
ContactAdam Gross
CorrespondentAdam Gross
MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo,  CA  93012
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-22
Decision Date2012-04-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630030807671 K120531 000
07630030807541 K120531 000

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