V40 ZIRCONIA FEMORAL HEADS

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

HOWMEDICA, INC.

The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for V40 Zirconia Femoral Heads.

Pre-market Notification Details

Device IDK972361
510k NumberK972361
Device Name:V40 ZIRCONIA FEMORAL HEADS
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford,  NJ  07070 -2584
ContactFrank Maas
CorrespondentFrank Maas
HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford,  NJ  07070 -2584
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-25
Decision Date1997-09-23
Summary:summary

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