S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD

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

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 Zirconia Cermamic Femoral Head.

Pre-market Notification Details

Device IDK921111
510k NumberK921111
Device Name:S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
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 CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-09
Decision Date1992-10-22

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