S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER

Prosthesis, Hip, Cement Restrictor

JOINT MEDICAL PRODUCTS CORP.

The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for S-rom(tm) Femoral Stem Centralizer/cement Spacer.

Pre-market Notification Details

Device IDK904746
510k NumberK904746
Device Name:S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER
ClassificationProsthesis, Hip, Cement Restrictor
Applicant JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford,  CT  06902
ContactDebra L Bing
CorrespondentDebra L Bing
JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford,  CT  06902
Product CodeJDK  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-18
Decision Date1990-11-20

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