THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for The P.c.a. Two-piece Snap Lock Acetabular Cup.

Pre-market Notification Details

Device IDK852153
510k NumberK852153
Device Name:THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactCharles H Lawyer
CorrespondentCharles H Lawyer
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-17
Decision Date1985-08-16

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