P.C.A. E-SERIES HIP- CEMENTLESS USE

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 P.c.a. E-series Hip- Cementless Use.

Pre-market Notification Details

Device IDK945093
510k NumberK945093
Device Name:P.C.A. E-SERIES HIP- CEMENTLESS USE
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford,  NJ  07070 -2584
ContactMary C Spicer
CorrespondentMary C Spicer
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 Received1994-10-17
Decision Date1995-01-19

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