ENCOMPASS 10/12 HIP STEM

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

ORTHO DEVELOPMENT CORP.

The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Encompass 10/12 Hip Stem.

Pre-market Notification Details

Device IDK132697
510k NumberK132697
Device Name:ENCOMPASS 10/12 HIP STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper,  UT  84020
ContactTom Haueter
CorrespondentTom Haueter
ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper,  UT  84020
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-29
Decision Date2014-06-20
Summary:summary

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