NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

JOINT MEDICAL PRODUCTS CORP.

The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for Noiles(tm) Total Knee Prosthesis, Modification.

Pre-market Notification Details

Device IDK905810
510k NumberK905810
Device Name:NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
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 CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-26
Decision Date1991-06-12

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