ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS

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

ORTHO DEVELOPMENT CORP.

The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Encompass Cemented Hip Stem & 10/12 Cobalt-chrome Femoral Heads.

Pre-market Notification Details

Device IDK050637
510k NumberK050637
Device Name:ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper,  UT  84020
ContactWilliam J Griffin
CorrespondentWilliam J Griffin
ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper,  UT  84020
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-11
Decision Date2005-09-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00822409012015 K050637 000
00822409011858 K050637 000
00822409011865 K050637 000
00822409011872 K050637 000
00822409011889 K050637 000
00822409011896 K050637 000
00822409011902 K050637 000
00822409011919 K050637 000
00822409011926 K050637 000
00822409011933 K050637 000
00822409011940 K050637 000
00822409011957 K050637 000
00822409011964 K050637 000
00822409011971 K050637 000
00822409011988 K050637 000
00822409011995 K050637 000
00822409012008 K050637 000
00822409011841 K050637 000

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