PRIMALOC CEMENTED HIP SYSTEM

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

ORTHO DEVELOPMENT CORP.

The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Primaloc Cemented Hip System.

Pre-market Notification Details

Device IDK962448
510k NumberK962448
Device Name:PRIMALOC CEMENTED HIP SYSTEM
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper,  UT  84020
ContactMichelle M Perry
CorrespondentMichelle M Perry
ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper,  UT  84020
Product CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-24
Decision Date1996-09-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00822409012992 K962448 000
00822409012800 K962448 000
00822409012817 K962448 000
00822409012824 K962448 000
00822409012831 K962448 000
00822409012848 K962448 000
00822409012855 K962448 000
00822409012862 K962448 000
00822409012879 K962448 000
00822409012886 K962448 000
00822409012947 K962448 000
00822409012954 K962448 000
00822409012961 K962448 000
00822409012978 K962448 000
00822409012985 K962448 000
00822409012794 K962448 000

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