MECTACER BIOLOX(R) DELTA FEMORAL 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(r) Delta Femoral Heads.

Pre-market Notification Details

Device IDK112115
510k NumberK112115
Device Name:MECTACER BIOLOX(R) DELTA FEMORAL 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-25
Decision Date2011-10-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630030809309 K112115 000
07630030809132 K112115 000
07630030809149 K112115 000
07630030809156 K112115 000
07630030809163 K112115 000
07630030809170 K112115 000
07630030809187 K112115 000
07630030809194 K112115 000
07630030809200 K112115 000
07630030809217 K112115 000
07630030809224 K112115 000
07630030809231 K112115 000
07630030809248 K112115 000
07630030809255 K112115 000
07630030809262 K112115 000
07630030809279 K112115 000
07630030809286 K112115 000
07630030809293 K112115 000
07630030809125 K112115 000

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