PERFECTA II/NON-COATED TOTAL HIP SYSTEM

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

ORTHOMET, INC.

The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Perfecta Ii/non-coated Total Hip System.

Pre-market Notification Details

Device IDK884027
510k NumberK884027
Device Name:PERFECTA II/NON-COATED TOTAL HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis,  MN  55439 -2713
ContactDennis H Crane
CorrespondentDennis H Crane
ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis,  MN  55439 -2713
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-23
Decision Date1989-04-07

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