HEADLOC CERAMIC HEAD

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

ORTHO DEVELOPMENT CORP.

The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Headloc Ceramic Head.

Pre-market Notification Details

Device IDK970675
510k NumberK970675
Device Name:HEADLOC CERAMIC HEAD
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper,  UT  84020
ContactCarol J Freasier
CorrespondentCarol J Freasier
ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper,  UT  84020
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-24
Decision Date1997-08-22

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