CL HIP STEM H/A COATED

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

LIMA INTL. CORP.

The following data is part of a premarket notification filed by Lima Intl. Corp. with the FDA for Cl Hip Stem H/a Coated.

Pre-market Notification Details

Device IDK922613
510k NumberK922613
Device Name:CL HIP STEM H/A COATED
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant LIMA INTL. CORP. 8021 KNUE ROAD, SUITE 121 Indianapolis,  IN  46250
ContactDouglas Stuart
CorrespondentDouglas Stuart
LIMA INTL. CORP. 8021 KNUE ROAD, SUITE 121 Indianapolis,  IN  46250
Product CodeMEH  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-02
Decision Date1994-04-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05051693300743 K922613 000
05051693300736 K922613 000
05051693300729 K922613 000
05051693300712 K922613 000
05051693300705 K922613 000
05051693300699 K922613 000

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