PRESS-FIT FLARED SHELL

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

ENCORE ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Press-fit Flared Shell.

Pre-market Notification Details

Device IDK960633
510k NumberK960633
Device Name:PRESS-FIT FLARED SHELL
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Applicant ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin,  TX  78757
ContactAshley M Bock
CorrespondentAshley M Bock
ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin,  TX  78757
Product CodeLWJ  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-14
Decision Date1996-10-01
Summary:summary

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