PCA 36MM FEMORAL HEADS

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Pca 36mm Femoral Heads.

Pre-market Notification Details

Device IDK061168
510k NumberK061168
Device Name:PCA 36MM FEMORAL HEADS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
ContactFrancisco Haro
CorrespondentFrancisco Haro
HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-27
Decision Date2006-07-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327138634 K061168 000
07613327138580 K061168 000
07613327138535 K061168 000
07613327138511 K061168 000
07613327138276 K061168 000

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