S-ROM(TM)/NOILES(TM) MARK 5 KNEE

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 S-rom(tm)/noiles(tm) Mark 5 Knee.

Pre-market Notification Details

Device IDK896397
510k NumberK896397
Device Name:S-ROM(TM)/NOILES(TM) MARK 5 KNEE
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 For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-07
Decision Date1990-02-22

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