SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT

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

LIMA INTL. CORP.

The following data is part of a premarket notification filed by Lima Intl. Corp. with the FDA for Sl-self Locking Total Hip-femoral Component.

Pre-market Notification Details

Device IDK902621
510k NumberK902621
Device Name:SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant LIMA INTL. CORP. 392 WAMPANOAG TRAIL E Providence,  RI  02915
ContactL Pollonio-lister
CorrespondentL Pollonio-lister
LIMA INTL. CORP. 392 WAMPANOAG TRAIL E Providence,  RI  02915
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-14
Decision Date1990-09-11

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