MECTACER BIOLOX OPTION HEADS

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 Mectacer Biolox Option Heads.

Pre-market Notification Details

Device IDK131518
510k NumberK131518
Device Name:MECTACER BIOLOX OPTION HEADS
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-28
Decision Date2013-11-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630030809408 K131518 000
07630030809392 K131518 000
07630030809385 K131518 000
07630030809378 K131518 000
07630030809361 K131518 000
07630030809354 K131518 000
07630030809347 K131518 000
07630030809330 K131518 000
07630030809323 K131518 000

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