KEYSTONE HIP

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

ENCORE ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Keystone Hip.

Pre-market Notification Details

Device IDK000521
510k NumberK000521
Device Name:KEYSTONE HIP
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin,  TX  78758
ContactDebbie De Los Santos
CorrespondentDebbie De Los Santos
ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin,  TX  78758
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-16
Decision Date2000-05-10

NIH GUDID Devices

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