NATURAL-KNEE TIBIAL AND FEMORAL SPACERS

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural-knee Tibial And Femoral Spacers.

Pre-market Notification Details

Device IDK915240
510k NumberK915240
Device Name:NATURAL-KNEE TIBIAL AND FEMORAL SPACERS
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactJ. D Webb
CorrespondentJ. D Webb
INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-21
Decision Date1992-01-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.